I bring you another story from the Cardiff University in UK, and this time it is not about some obscure dishonest professor and small change off Traditional Chinese Medicine. This time, it is about this Welsh university’s former President, Sir Martin Evans, winner of the Nobel Prize of 2007, for his “discoveries of principles for introducing specific gene modifications in mice by the use of embryonic stem cells”. And unlike another Nobelist, Louis Ignarro, Evans did not undersell his Nobel honours to peddle pomegranate juice and Herbalife supplements, he instead set up some serious business of his own. Together with a struck-off dentist Ajan Reginald, Evans founded in 2009 the company Cell Therapy Ltd, which now goes by the name Celixir. Evans is the official director of the company, and he even presented his new start-up on the BBC hit show “Dragon’s Den” same year.
The company sells, what else, stem cells, derived from bone marrow which Evans and Reginald call iMPs. Some serious money is flowing, and clinical trials are happening. The idea is to cure heart patients with patented cells, and it is clear as mud what kind of cells those are. In the initial experiment performed in Greece in 2009 it used to be patients’ own bone marrow cells, which in the clinical trial changed to unspecified “healthy donor” mesenchymal cells, but now in an upcoming next stage clinical trial in UK, yet another kind of proprietary cells is to be used. The issue of immune-rejection is to be addressed by some mysterious “genetic engineering”, for which however no approvals were issued.
It is well known who Sir Martin Evans is, and all the many awards and honours he received. But it is worth reading up who his closest business associate Ajan Reginald is.
Reginald is namely a struck-off dentist, his own lawyers insisted that he suffers from “cognitive difficulties”. This was reported by Wales Online in 2012 :
“Mr Reginald, now aged 40, was struck off as a dentist in 2005 after a professional committee found he had mistreated 24 of his patients at a practice in Redditch, Worcestershire. One of the complainants was left in “absolute agony” after he drilled through a tooth into her gum. He had failed to fit crowns properly, provided such poor root canal treatment that teeth were lost and carried out bridge work that was unnecessary.
Mr Reginald was found guilty of serious professional misconduct and of making dishonest claims to the Dental Practice Board in respect of work not done on 20 named patients. At the end of the General Dental Council conduct hearing, chairman Professor Colin Smith said he had to be struck off to protect the public, adding that the committee had taken into account information from Mr Reginald’s solicitors in relation to his medical condition and “cognitive difficulties”, but said this would not explain many facts proved against him.
On subsequent CVs, Mr Reginald made no reference to his period as a dentist dating from 1996 when he qualified.”
At that time Reginald pretended to be affiliated with the Institute of Life Sciences in Swansea University, which proved not true. He also used to call himself Dr Reginald and was listed to have a PhD degree from Northwestern University in Evanston, Illinois, awarded to him in 2006. Wales Online wrote:
“We asked the university whether Mr Reginald had been awarded a PhD. A spokeswoman confirmed he had not, adding: “Ajanthan Reginald attended Kellogg from September 2002 to June 2004 and received a Master of Business Administration on June 18, 2004.”
Reginald is a ruthless businessman, and this is what made him filthily rich. In 2011, The Times reported how he apparently tricked an autistic inventor, Jason Perkins, whom he apparently met at Evans’ pitch at Dragon’s Den in 2009:
“The Peepo is an electronic device that blind people hold in their left hand along with
the lead of their guide dog. It can be voice-activated by saying a postcode. It then guides the owner by sending pulses to different parts of the hand. Perkins said:
“I just wanted to help people who had greater challenges than I did. But something has gone wrong somewhere. My illness means I don’t fully understand people’s emotions or intentions and I am far too trusting.”
At a Dragons’ Den-style evening at Cardiff city hall Dr Ajan Reginald, 39, offered to
invest in the company if he could become a director. Perkins said:
“Once he was a director he said that if I didn’t sign over my patent it was illegal. He kept using language I didn’t understand. I feel awful now that the company could be struck off.”
Reginald claims he took control of the firm when Perkins went to Canada to start a
new life. Perkins says he went for less than a month to recuperate after coming closeto a mental breakdown.”
None of that ever mattered to Evans. And why should it? In 2016, his business partner Reginald helped Sir Martin to some serious money: the iMP technology was licenced to a company in Japan, paid upfront:
“Daiichi Sankyo will undertake all development, regulatory and commercial activities for iMP cells in the territory of Japan only, while CTL retains its worldwide rights outside of Japan as well as global manufacturing responsibilities. Under the terms of the agreement, CTL receives a £12.5 million upfront licensing fee and additional milestone payments and royalties.”
In 2017, Reginald paid himself a salary of £ 633,533 from Cell Therapy Ltd funds, £300k more than the previous year. Evan’s own benefits went from less than £9500 to over £125k. The big money from Japan was possible because of this 2016 paper describing the Phase 2a clinical trial at AHEPA University Hospital in Thessaloniki, Greece:
Kyriakos Anastasiadis, Polychronis Antonitsis, Stephen Westaby, Ajan Reginald, Sabena Sultan, Argirios Doumas, George Efthimiadis and Martin John Evans
Implantation of a Novel Allogeneic Mesenchymal Precursor Cell Type in Patients with Ischemic Cardiomyopathy Undergoing Coronary Artery Bypass Grafting: an Open Label Phase IIa Trial
Journal of Cardiovascular Translational Research, 01 April 2016. DOI: 10.1007/s12265-016-9686-0
Reginald’s affiliation is provided as “Experimental Therapeutics, University of Oxford”, yet the university staff register holds no records of his affiliation there (according to his LinkedIn profile, he might have been MSc student in Oxford). Another coauthor, Sabena Sultan (“Global Head of Research” at Celixir) listed as her affiliation as “John Radcliffe Hospital, Oxford University Hospitals, Headington, Oxford, UK”. The hospital provided this information however:
“There are no Human Resources (HR) records for this individual in relation to her employment as a member of staff or as a honorary contract holder”.
This is the paper’s abstract:
“Heart failure is a life-limiting condition affecting over 40 million patients worldwide. Ischemic cardiomyopathy (ICM) is the most common cause. This study investigates in situ cardiac regeneration utilizing precision delivery of a novel mesenchymal precursor cell type (iMP) during coronary artery bypass surgery (CABG) in patients with ischemic cardiomyopathy (LVEF < 40 %). The phase IIa safety study was designed to enroll 11 patients. Preoperative scintigraphy imaging (SPECT) was used to identify hibernating myocardium not suitable for conventional myocardial revascularization for iMP implantation. iMP cells were implanted intramyocardially in predefined viable peri-infarct areas that showed poor perfusion, which could not be grafted due to poor target vessel quality. Postoperatively, SPECT was then used to identify changes in scar area. Intramyocardial implantation of iMP cells with CABG was safe with preliminary evidence of efficacy of improved myocardial contractility and perfusion of nonrevascularized territories resulting in a significant reduction in left ventricular scar area at 12 months after treatment. Clinical improvement was associated with a significant improvement in quality of life at 6 months posttreatment in all patients. The results suggest the potential for in situ myocardial regeneration in ischemic heart failure by delivery of iMP cells."
The associate medical director at the British Heart Foundation, Jeremy Pearson, raised a valid criticism of this study:
“This very small study suggests that targeted injection into the heart of carefully prepared cells from a healthy donor during bypass surgery, is safe. It is difficult to be sure that the cells had a beneficial effect because all patients were undergoing bypass surgery at the same time, which would usually improve heart function”.
Indeed, you can combine bypass surgery with prayer dirges and shamanic dance, and then claim that it was actually the ceremony which helped the patients. Problem is, you can’t patent shamanic dancing, even if it brings much less infection risk with it than injection of lab-expanded cells into a heart. Nevertheless, the stem cell success story was celebrated in all the big newspapers in UK: in The Guardian, The Telegraph, on BBC, and of course also in Greece. And yet, nobody bothered to ask what the magical stem cells actually were.
The proprietary product, injected into the hearts of 11 patients in Greece in this Phase 2a clinical trial in 2012-2013, was presented as “a novel mesenchymal precursor cell type (iMP)”:
“iMPs are a novel and distinct mesenchymal precursor cell type discovered and isolated by Cell Therapy Limited, UK (CTL), as a potent cellular therapy intended for cellular therapy in cardiac regeneration”.
These cells seem to be some kind of macrophages from how they are described in the paper. However, when the trial was registered on ClinicalTrials.gov in December 2012, it spoke of “allogeneic mesenchymal stem cells”, not of the magic iMPs. And even before that, in 2010, Reginald announced a different methodology:
“The new treatment can be rolled out so soon because the cell therapy pioneered by the firm uses the patient’s own cells and is essentially a transplant – so it does not follow complex regulatory approval associated with new medicines. It would be administered in hospital through an IV drip, which the company’s founders say will mean that it will be easy for hospitals to use.”
There is no source of funding provided in the Anastasiadis et al 2016 paper, and this is not a minor issue. Of note, right after the paper was published, Reginald registered a new company in Thessaloniki: Cellular Treatment Greece. Clinical trials are very expensive, hence who paid for it and why is the source of money secret? The trial was originally scheduled to recruit 30 patients, but in Anastasiadis et al 2016 the authors claim: “The phase IIa safety study was designed to enroll 11 patients”. Maybe the clinical trial run out of money, maybe the missing 19 patients did not return for evaluation, having died (of course of utterly unrelated causes) or showed some undesired adverse effects, and thus disqualified themselves from being included in the final paper.
Now Reginald and Evans intend to recruit 50 patients: a new phase 2b clinical trial is to follow in UK, at the Royal Brompton & Harefield NHS Foundation Trust hospital. It is scheduled to begin right now, when you read this story, in April 2019.
The key figure, who made the Greek stem cell clinical trial possible, is the famous British heart surgeon Stephen Westaby, aged 71. He now acts as Chief Medical Officer for cardiology with Celixir. In 2013, he was listed as shareholder with this company, but he forgot to declare those conflicts of interest in the Anastasiadis et al 2016 paper. This is how Westaby once described himself in a newspaper article:
“At medical school I went from being a nice, considerate young man who wouldn’t say boo to a goose to an aggressive young man who by then was fit to be a heart surgeon. I got injured playing rugby — a bi-frontal head trauma that causes psychopathy — and I had a complete personality change. If you look at psychopaths’ brains on MRI scans, they’re short of grey matter at the front. I wasn’t born like that, but somebody provided me with it. And what we know now actually, is that a very high number of surgeons score very, very highly on the psychopathic assessment lists. You’ve got to have the characteristics of a psychopath to make a good surgeon”.
Evans and Reginald did wise to recruit Westaby to their business. He was namely the lead author on a compassionate use study with bone marrow cells with one patient, performed at AHEPA University Hospital in Thessaloniki in 2009, and celebrated in UK’s newspaper Daily Mail. The results were published with same Greek co-authors only 3 years later, in 2012, then without Evans or Reginald:
Kyriakos Anastasiadis, Polychronis Antonitsisa, Argirios Doumas, Georgios Koliakos, Helena Argiriadou, Christina Vaitsopoulou, Paschalis Tossios, Christos Papakonstantinou, Stephen Westaby
Stem cells transplantation combined with long-term mechanical circulatory support enhances myocardial viability in end-stage ischemic cardiomyopathy
International Journal of Cardiology (2012) DOI: https://doi.org/10.1016/j.ijcard.2011.07.062
Now, Westaby is fully behind Celixir’s technology and advertises for the new phase 2b clinical trial at Royal Brompton, calling the method “bloody marvellous”. the iMPs are now called “Heartcel” and Westaby claims, out of the blue, that those are genetically engineered:
“During production it undergoes genetic engineering making it “immune privileged”, meaning it is biologically acceptable to all recipients and will not be rejected”.
Nowhere does Anastasiadis et al 2016 paper make any mention of any gene engineering, nothing is being turned “immune privileged” there. In the Anastasiadis et al 2012 case report, the patient received his own cells, the Anastasiadis et al 2016 paper speaks of “bone marrow aspirate from a healthy donor” without telling any details, or where the cells were stored and cultured. There is certainly no mention of any “immune privileged” engineering there. The UK Human Tissue Authority, which would be in charge of regulating such gene-engineered cells, replied:
“over two years ago, Celixir did apply for a licence from the HTA and a site visit was conducted. However, the activities they described as being undertaken at that time were considered not to be licensable activities.”
It is actually not at all clear which cells the authors have used in Greece and which they intend to use in UK. Patricia Murray, professor of stem cell biology and regenerative medicine at the University of Liverpool, is the one who researched the information presented in this article, after having heard the Phase 2b clinical trial at Brompton. She explains her concerns:
“The protocol in the paper describes a method for isolating mononuclear cells from bone marrow aspirates (BM-MNCs). It is not clear why the authors describe the cells as ‘immunomodulatory progenitor cells (iMPs)’. It would be expected that the BM-MNC population contains monocytes, which can differentiate to macrophages and dendritic cells, so maybe the authors are referring to the monocyte component of the population as ‘iMPs’? They state in the discussion that the ‘iMPs’ do not express the monocyte marker, CD14, but results are not shown for that. The authors do not appear to have published a paper showing detailed characterisation of the ‘iMPs’.
A recent paper from the FDA states the following: “…to ensure that [stem cell therapy] fulfils its promise to patients, we must first understand its risks and benefits and develop therapeutic approaches based on sound science. Without a commitment to the principles of adequate evidence generation that have led to so much medical progress, we may never see stem-cell therapy reach its full potential.” (Marks et al (2017) NEJM 376;11 1007-9).
It seems that in some cases, the drive to commercialise ‘stem cell’ therapies is taking priority over these important principles.”
Another former associate at Reginald’s & Evans’ Cell Therapy Ltd/Celixir used to be the former First Minister of Wales, Rhodri Morgan. Morgan was appointed in 2013 President of Cell Therapy Ltd, and this is how he was quoted in Wales Online back then:
“I was very lucky, after my heart attack I had zero heart muscle damage. What stem cell therapy gives us is the opportunity to repair damaged heart muscle. Hitherto it’s been un-repairable,” he said.
“It’s a very exciting Welsh company with world beating technology of very high value to patients with heart diseases. We believe the same technology could be applied to knee problems and gynaecological problems.”
With Morgan’s help, Reginald and Evans’s business partnered with Chinese firm Shijiazhuang in order to produce bioreactors for heart stem cells. Morgan couldn’t fully profit from the tremendous regmed cash flow, as the Welsh politician died in 2017, the company was valued at £200 million at that time. Now Evan is back to being the company’s president.
Evans and Reginald have big business plans. They even patented a type of mesodermal progenitor cells to cure cancer.
It seems Sir Martin and Mr Reginald engaged in plagiarism.
This patent for the “progenitor cells of mesodermal lineage” (PMLs) that was filed in 2012, among its authors is Sir Martin. It says that the same culture conditions used to generate mesecnhymal stem cells (MSCs) from bone marrow can be used to generate ‘PMLs’. Yet on pages 4 and 6 it says:
“Fig. 5 shows that progenitor cells of mesodermal lineage migrate to the fracture site in a time and CXCR4 dependent manner. Bioluminescence (BLI) was performed at days 1 (ﬁrst row), 3 (second row), 7 (third row) and l4 (fourth row) after fracture / transplantation in mice with tibia fracture that received a transplant of either 10^6 PML P Act Luc (PML) (left column), PML ﬂ Act Luc CXCR4+(CXCR4(+)) (middle column), or PML P Act Luc CXCR4 (CXCR4( )) (right column). […]
The PMLs of the invention are not stem cells. In particular, they are not mesenchymal stem cells (MSCs).”
Big problem here is that Fig 5 is a plagiarised and misrepresented data-set from a manuscript that was published by other scientists 3 years before, in a Wiley journal: Granero-Moltó et al, Stem Cells, 2009. The paper and the Celixir patent share no common authors. The cells in GraneroMolto et al 2009t are in fact MSCs, the Figure 1A legend goes:
“Figure 1. MSC migrate to the fracture site in a time- and CXCR4-dependent manner
(A): BLI was performed at day 1, 3, 7 and 14 after fracture/transplant in mice with tibia
fracture transplanted either with 10^6 MSC- β -Act-Luc (MSC) (left panel), MSC- β -Act-Luc-CXCR4+ (CXCR-4+) (middle panel) or MSC- β -Act-Luc-CXCR4-(CXCR-4−) (right panel). Graded color bar indicates BLI signal intensity expressed as photons/sec/cm^2/sr.”
So it looks like Celixir’s business model and clinical trials on up to 150 patients are based on a false patent which contains plagiarised material.
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a bi-frontal head trauma that causes psychopathy
Psychopathy is not caused by frontal-lobe injuries. Westaby may well have lobotomised himself, but any psychopathy was there all along.
Mark Beards, Corporate Development Director for Celixir talks about the history of the company here and the key to its success:
“He [Martin Evans] was the first ever person to find a stem cell. He won a Nobel prize for that. […] His expertise is in finding rare cells and the company is built around that expertise. We are finding cells every year that have very specific functional activity in different diseases.”
“Getting on to how we capture the value of our technology, we look at the cell surface receptors to characterise our cells. This is traditionally how companies look at the cells to not only understand what those cells can do but also to put intellectual property round them.”
“We look at 369 surface receptor markers […] versus the current competition which looks at only a handful of those markers, se we’re very highly characterising and protecting ourselves. Because of that we are able to select cells that are highly homogenous and very very easy to grow in a laboratory so we only need 4 doublings to get to the population that we need to treat. Our very low Cost of Goods [10%] are driven by this but also very quick time to develop those products into a therapeutic.”
This doesn’t make sense because if the cells they are finding are rare and they have to select them (presumably using MACS or FACS, which considerably reduced yield), how can 4 doublings generate sufficient numbers for therapeutic use?
The patents can be found here: https://patents.justia.com/inventor/ajan-reginald
An investor pitch by Cell Therapy Ltd from 2016, see file here.
We learn what these mysterious iMPs are:
This is interesting. Sir Martin believes that bone marrow cells are near-pluripotent. Well, he is the expert here. The 50 patient phase 2b trial seems just the beginning:
Oh, and now we know that it was not genetic engineering as Dr Westaby claimed, but “epigenetic modification”. Is Sir Martin serious with his buzzwords?
This is interesting. 3 GLP facilities sounds fancy, but it also means no GMP facilities. Is Celixir culturing patient cells for in-human use in animal research labs?
Oh. The human cell material for phase 2a clinical trial in Greece (2012-2013) was indeed prepared for animal research-certified lab. The GMP certificate came 4 years later.
page 30/35 Financial Report:
One inventor of the above discussed patent is Ina Laura Pieper. She is reported to have done her PhD with Cell Therapy Ltd/Celixir, funded by the Prince of Wales Innovation Scholars (POWIS) programme
Her PhD thesis with Swansea University is embargoed until April 2020 the earliest:
Product development of a mesenchymal stem cell therapy for the treatment of myocardial infarction : developing the Enhancell™ product pipeline for Cell Therapy Limited / Ina Laura Pieper.
College of Medicine. Thesis (Ph.D.) – Swansea University, 2014
In 2014, Reginald gave a presentation for IWA Science & Technology Award (starts at 1:40):
He presents his proprietary bone-marrow-derived iMP stem cells which he says were injected into patients’ hearts.
Yet the photo of these cells comes from a paper Pieper published in 2017:
Ina Laura Pieper, Rachel Smith, Joanna C. Bishop,Omar Aldalati, Alex J. Chase, Gareth Morgan, Catherine A. Thornton
Isolation of Mesenchymal Stromal Cells From Peripheral Blood of ST Elevation Myocardial Infarction Patients
First published: 28 February 2017 https://doi.org/10.1111/aor.12829
The figure shows peripheral blood cells, and the paper never mentions Celixir or Cell Therapy Ltd or Reginald.
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It’s called due diligence, folks. Any person or business who gives these guys a dime should only do so after serious scrutiny. Any institution that hosts their research should have proper ethical review, which I’m guessing ain’t so much an issue in Greece. There’s a lot of fake news and snake oil out there, and those who fall for it get what they deserve. That Celixir presentation is high comedy.
Among the scientists who vote for the Nobel Prize might very well be also those ones who have comments in PubPeer, retract papers, etc
An interview with Celixir’s CEO, Ajan Reginald, reveals some concerning information:
Information relating to the cells that were used in a trial in Greece:
“We took a cell and modified it to make it heart-specific and then we modified it again to make it very good at reducing scar in the heart.”
“We were beautifully lucky.”
“This medicine seems to have a profound effect in reducing scar in patients and that’s the first time that has been seen in humans.”
From this, it seems that appropriate safety and efficacy tests were not conducted in animal models prior to the cells being tested in patients. There is no information indicating how the cells were modified. Questions need to be asked about why this initial trial was conducted in Greece rather than the UK.
The CEO goes on to say:
“All of our innovation is done in-house.”
This suggests that the cells used in the Greek trial were prepared at the University of Life Sciences, University of Swansea. It appears that the company did not have a GMP facility at Swansea. Did the company have the necessary approvals from HTA and MHRA?
There are questions relating to where the cells were sourced from. In the 2016 paper that reports on the Greek trial (conducted in 2012-2013), it is claimed that the ‘iMPs’ were allogeneic and sourced from bone marrow donors. Yet in this article, it seems that Celixir’s cells are isolated from blood donors:
Click to access ACF-Celixir-formerly-CTL-Valuation-22072015.pdf
“Cell Therapy Ltd (CTL) is a biotech regenerative healthcare platform play with novel stem cell medicines. CTL possesses a proprietary process, extracting novel stem cells from donated blood.”
It would be interesting to know exactly what the patients in the Greek trial consented to.
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Nobelist Prof Evans’s toil
Produced bottles of stem cell snake oil
He met ‘Doctor’ Trevor
A fraudster so clever
And fleeced many miliions from all
Martin Evans –breaking bad.
If Evans had never met Ajan Reginald, maybe we would have stayed on the straight and narrow.
But just 2 years after the pair went into business together, they filed a fraudulent patent. After that it was downhill all the way, with Evans helping to make a scam promo video, featuring as senior author on a dodgy manuscript and helping to trick companies into handing over huge licence fees for the right to use BS cells called ‘iMPs’.
The bad behaviour wasn’t restricted to fleecing investors.
In 2014 Evans caused huge embarrassment to Cardiff Uni and VC Colin Riordan by refusing to step down from his position as Chancellor (an honorary unpaid role).
The story was covered in most newspapers but the most complete version is probably here:
Click to access 1028.pdf
For about 130 years, it has been the tradition at Cardiff Uni to appoint a new Chancellor every 5 years. Evans’s first term was up in 2014 and the VC proposed Griff Rhys Jones as a replacement. This was seconded by the Uni’s Council. It was then for the Uni’s Court to ratify the decision, but unexpectedly, one of the Profs in the Court, who is likely a mate of Evans, expressed outrage that Evans was not offered another term. Never mind that Rhys Jones had already accepted the position, and it would be clearly very embarrassing for the Uni to withdraw its invitation to him at this late stage. Evans didn’t care about any of that, smugly stating that he would be willing to stand again.
It kind of looks like Evans twisted arms of those in Court to push for his re-election. The VC was understandably furious. And after all that kerfuffle, Evans resigned in 2017 before completing his 5 year term.
Why was Evans so keen to be re-elected? Who knows, but during his second term as Chancellor he published a paper about a dodgy Greek trial, listing Cardiff Uni as his place of work. After the paper was published he stepped down.
But Mr Digbeard, surely a gentleman of the world like yourself will appreciate the following :
In 2015, Cardiff Chancellor Sir Martin Evans dug with both his hands into another financially rewarding enterprise: Traditional Chinese Medicine (TCM).
Observe this: https://www.cardiff.ac.uk/cy/news/view/237514-cardiff-to-advise-capital-medical-universitys-key-laboratory
The Chinese gentleman next to Sir Martin is Wen Jiang, professor of the Cardiff University. His research fields involve TCM quackery and Photoshop, both deployed to pretend to cure cancer. Prof Jiang is very well connected to a Chinese TCM billionaire who pays both Jiang and Cardiff University in return for their endorsement of his TCM concoctions.
This is why Cardiff University declared all those many fraudulent Jiang et al papers to be free of misconduct and publicly accused me of having slandered him.
“With Morgan’s help, Reginald and Evans’s business partnered with Chinese firm Shijiazhuang in order to produce bioreactors for heart stem cells.”
It appears that Walesonline (your source link here) was misinformed, or rather whoever wrote the press release they reprinted was misinformed, because “Shijiazhuang” is the name of a city, rather than a company.
This appears to be a more accurate description of the joint venture: http://global.chinadaily.com.cn/a/201408/11/WS5a2fd4bfa3108bc8c672a7d9.html
The company name is “Union Shengxin Pump Industry”, and they are based in Shijiazhuang. Precisely how their experience in manufacturing industrial slurry pumps suited them to build desk-top stem-cell-multiplying bioreactors is an open question. We read that
Now all of this is a lie. The Company House records for Bioreactor Corporation reveal that it is just one person (another Ajan Reginald corporate entity), it employs no-one, and has net assets of £1. There is one shareholder (“Trevor Reginald”) holding its single share (valued at £1). It is a toy.
It is clear why the Union Shengxin Slurry-Pump company lied to China Daily: they want to raise their profile. “Union Shengxin, which is listed on the Tianjin Equity Exchange, wants to receive more global exposure by listing overseas, and is preparing to do so on the Frankfurt Stock Exchange before the end of the year.” So no sign of the yearly production of 50,000 desk-top stem-cell factories they were promising in 2014.
Ajan Reginald appears to have gone along with the fraud, but of course it is possible that the quotes attributed to him in the China Daily story were fabricated by someone else, and that he misinformed WalesOnline only because the company had taken advantage of his naive nature.
This parenthetical note within the 2014 ChinaDaily story caught my eye:
“Two years ago Cell Therapy started a partnership with Zhongyuan Union Stem Cell Bioengineering, a Tianjin company founded in 2008, to develop an unrelated technology in stem cell medicines.
“The two partners established a joint venture to research and develop a new type of innovative stem cell medicine for heart disease, which may begin clinical trials soon, and if all goes as hoped the medicines could be put on the market in about four years.
“Zhongyuan Union is the majority shareholder of the joint venture, which has a research laboratory in Tianjin.”
This seems to relate to a 2013 announcement, triumphantly proclaimed through WalesOnline and conveniently broken into short sentences / paragraphs for ease of reading:
Cardiff-based biotech company Cell Therapy Limited (CTL) has entered into a new joint-venture agreement with a Chinese company.
CTL is developing stem-cell therapies at its laboratories to combat life-threatening and serious life-altering illnesses such as heart disease and diabetes.
It has signed a joint-venture agreement with Chinese firm Zhongyuan Union Stem Cell Bio-engineering Corporation (Union).
The new deal will see CTL establishing the joint venture with Union in multiple cities across China and developing large operational hubs near Shanghai and Beijing, with CTL holding nearly half of the shares in the new company.
It will also give the firm half of the revenues generated by the joint venture in China and first option to all of Union’s products outside China.
It could also see the creation of new jobs in Wales to support the new venture and to continue CTL’s commercialisation activity across Europe and America.
CTL was founded in Cardiff in 2009 by Nobel Laureate Professor Sir Martin Evans and executive director Ajan Reginald.
Mr Reginald said: “CTL was founded to develop life-saving and life-changing medicines.
“This partnership is very focused and enables CTL to accelerate development of treatments for heart disease and diabetes while accessing the growing China market.
“We thank and congratulate our small but talented team and generous supporters – this partnership recognises their exceptional work and dedication.”
The joint-venture agreement was signed by Sir Martin in Tianjin.
Stem-cell therapy is at the cutting edge of cardiovascular treatment, offering the potential to repair heart tissue immediately after a heart attack or heart failure.
The stem-cell market is forecast to triple from £13bn to £40bn by 2015 and CTL hopes its work will enable Wales to tap into this fast-growing hi-tech market and create hundreds of jobs.
Union is a domestic life science and technology enterprise. Li Defu, chairman of its parent company Tianjin Vcanland Group, said the two companies would push forward the development of China’s stem-cell industry.
Former First Minister Rhodri Morgan joined the board of CTL earlier this year.
It is hoping for off-shelf stem-cell medicine for heart failure to be on the market by 2016. It said it does not envisage any need for additional funding.
Evidently the press release was circulated widelya and here I quote a description of the Joint Venture from BioSpectrumAsia:
Cell Therapy Limited (CTL), which is based in Cardiff, UK, entered into a joint venture (JV) agreement with Chinese firm Zhongyuan Union Stem Cell Bio-engineering to develop stem cell therapies in order to combat life-threatening ailments such as heart disease and diabetes.
The new deal will see the two firms form JV in multiple cities across China and developing large operational hubs near Shanghai and Beijing. The JV will also see the two firms share half of the revenues generated in China and will provide first option to all of Zhongyuan Union’s products outside China.
CTL was founded in Cardiff in 2009 by Nobel Laureate professor Sir Martin Evans and executive director Mr Ajan Reginald. The JV agreement was signed by Sir Martin in Tianjin, China, along with Mr Li Defu, chairman of Zhongyuan Union’s parent company Tianjin Vcanland.
Mr Reginald, while speaking about the JV, said that, “CTL was founded to develop life-saving and life-changing medicines. This partnership is very focused and enables CTL to accelerate development of treatments for heart disease and diabetes while accessing the growing China market. “We thank and congratulate our small but talented team and generous supporters, this partnership recognizes their exceptional work and dedication.”
So all that was six years ago. I can’t find any more press releases proclaiming further developments. Does anyone know how the Zhongyuan Union company is progressing with CTL / Elixir’s technology?
I also like this part of the 2014 press release:
“Cell Therapy was founded in 2009 by the Nobel laureate Martin Evans and Reginald, who previously worked as global head of emerging technologies at Roche. It now employs about 20 people.”
I assume that this was another fabrication from the Union Shengxin Slurry-Pump company.
Actually Ajan himself tells all and sundry that he used to be Global Head at Roche. When I wrote to Roche, they said they can’t comment “due to data privacy regulations”.
What’s funny is that after Roche, Ajan took up a position as Director of Corporate Relations at Warwick University. Presumably he was Dr Reginald PhD at that time. As with Roche, Warwick has wiped all traces of him, except for proudly announcing that there was an article him in the Western Mail. See penultimate link here:
There were actually 3 articles, but nothing for Warwick to be proud of here!
Ajan ‘resigned’ a few weeks before the first of those articles came out.
Ajan Reginald deserves an apology. Those newspaper articles in the above links were incorrect.
And so are these:
The true picture is given in the blog post below:
Brief summary: Ajan Reginald explains that he was not struck of the dental register for damaging patients and claiming £££ for work he didn’t too. Definitely not! It was a “horrific sports injury” that caused Ajan to “retire” from dentistry.
Ajan is now devoting his life to developing stem cell therapies to treat incurable diseases. And this is not because he is hoping to make big profits of £72K per shot. It is because he wants to serve humanity.
Unbelievably, instead of being celebrated, Ajan finds he is in the “crosshairs” of evil “trolls” who “spout vile stuff and nonsense in an attempt to besmirch his incredible work”.
But being the upstanding fellow he is, Ajan is not deterred and magnanimously declares that these trolls may be the very people whose lives are saved by his “revolutionary medical breakthroughs”.
What was Ajan doing when we was at Warwick? (see comment from Nov 12th above).
There is a clue. Ajan spoke at a conference in 2012 in Italy and gave his affiliation as Cell Therapies Ltd, University of Warwick. Was the company based there in 2012?:
Click to access 201206_international_symposium_cell_gene_based_program.pdf
Why is Ajan being so shy about his achievements at Warwick?
There is a new Ajan Reginald site:
Here we learn that the great man is “actually entirely various”.
His therapies are “the most effective to cure, boost, mend, replace, or replenish organs, tissues, cells, genetics, along with improve the metabolic procedures in the body.”
Little wonder he has the endorsement of great luminaries like Martin Evans, Stephen Westaby, Armand Keating, Kim Fox, John Pepper, etc: https://www.celixir.com/our-people/
The last part of the above blog is something of a revelation. It turns our that Martin Evans did not get a Nobel for his work with mouse embryonic stem cells.
According to Ajan, it was for “presenting specific genetics adjustments in computer mice by the use of embryonic stalk tissues”.
This surely explains why MHRA did not hesitate to give their approval for them to undertake a clinical trial.
Dear Mr Digbeards, I fear we drove poor Ajan insane.
“Ajan Reginald was actually founded due to the Professor Sir Martin Evans and Ajan Reginald, that are actually popular individual and also recognized to the all over the world as a result of great work”
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Thanks to Patricia Murray for staying on this!
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On 22nd January 2020, Stephanie McNeil from the US Patent and Trademark Office (USPTO) issued a ‘final rejection’ of Celixir’s iMP patent: https://portal.uspto.gov/pair/PublicPair
USPTO tells Celixir their claims are rejected as being unpatentable over:
• Hanley et al (2013, Cytotherapy; 16: 1048-58: “Efficient manufacturing of therapeutic mesenchymal stromal cells with the use of Quantum Expansion System”)
• Schallmoser et al (2009, Bio-Medcial Materials and Engineering 19:271-275: “Platelet-derived growth factors for GMP-compliant propagation of mesenchymal stromal cells”)
• Salem et al (2010, Stem cells 28:585-596: “Mesenchymal stromal cells: current understanding and clinical status”).
McNeil from the US PTO says:
“The prior art cells [i.e., the MSCs described in the above papers] are produced by the same method as the claimed cells [i.e., Celixir’s ‘iMPs’], they are both produced from bone marrow mononuclear cells from a patient, cultured in the same conditions as the claimed cells. Additionally, Salem teaches that MSCs inherently expressed many of the same markers as the claimed cells [the ‘iMPs’]. The cited art taken as a whole demonsrates a reasonable probability that the cells of the prior art is either identical or sufficiently similar to the claimed cells that whatever differences exist are not patentably significant. Specifically, since all the active steps in the method are rendered obvious over Hanley in view of Salem and Schallmoser, the result of said method steps, namely the expression pattern of the cells, is also obvious.”
Or to put it simply, the ‘iMPs’ are not patentable because they are MSCs.
This begs the question, why did Daiichi Sankyo pay an upfront licensing fee of £12.5M to Celixir for the privilege of using MSCs?
Ajan has applied to strike off his company Myocardion. This is the name given to the magic “cells of mesodermal lineage” (PMLs) that are the precursors of the even more magical “iMPs”.
The request to strike off is signed by Trevor Reginald, and co-signed by his best friend, Ajan Reginald: