Trial Report REGENECYTE cord blood cell therapy in post-COVID syndrome: a phase IIa randomized, placebo-controlled trial, 2026, Huang et al

[Paraprosdokian]

This post is about a press release in 2024. The study is now published in 2026.
See post #7

A large company specialising in umbilical cord blood has conducted a successful phase 2a trial in Long Covid patients (20 LC patients, 10 controls). The UCB contains Haemopoietic Progenitor Cells (which are the things that form from stem cells before they turn into blood cells). See here for an overview.

It was found to be safe with lower treatment-emergent adverse events (primary endpoint) and to reduce fatigue as measured by the Chalder scale.

Based on a press release, its difficult to tell how successful it was. They don't say how much the Chalder fatigue scores fell, only that 85% of patients in the treatment arm fell below a score of 4 (compared to 20% in the control arm). Who knows if the threshold of 4 was a pre-determined benchmark or the nicest way to present the numbers to the market. The company is being listed on the Taiwan stock exchange this month.

The FDA, however, seem to think this is promising. It's granted Regenerative Medicine Advanced Therapy (RMAT) designation to UCB for the use in LC on the strength of these results. It's a fast track for novel treatments for serious illnesses.

I think its a possible path forward. Perhaps the UCB is regenerating white blood cells and that is causing improvement. Or perhaps someone thought "stem cells regenerate things, let's roll the dice and cross our fingers that it works".

Link to press release announcing phase 2 results: https://www.prnewswire.com/news-rel...e-relief-from-fatigue-symptoms-302336656.html

Link to clinical trial: https://clinicaltrials.gov/study/NCT05682560

Edit: Fixed a typo

 

[Jonathan Edwards]

The study says it was 'single blind' which basically means that it was not fully blinded. The control was saline rather than blood. Either the patient or the administrator knew which was which. That makes it more or less worthless.

 

[Paraprosdokian]

Haha, well spotted. I missed that.

It's blinded to the patients, but surely even patients would realise the clear solution being fed to them isn't blood. Which means it wasn't blinded at all.

I wonder why the FDA gave them fast track status.

 

[Jonathan Edwards]

I wonder why the FDA gave them fast track status.

Probably because 'regenerative medicine' is a bullshit concept and the relevant committees are manned by idiots.

 

[MeSci]

A large company specialising in umbilical cord blood has conducted a successful phase 2a trial in Long Covid patients (20 LC patients, 10 controls). The UBC contains Haemopoietic Progenitor Cells (which are the things that form from stem cells before they turn into blood cells). See here for an overview.

I think that the abbreviation is UCB, rather than UBC? Standing for umbilical cord blood.

 

[Jonathan Edwards]

Or perhaps someone thought "stem cells regenerate things, let's roll the dice and cross our fingers that it works".

Perhaps to explain the absurdity of this a bit more:
If these cells are supposed to be 'regenerative' there are two possibilities.
1. The recipient's immune system kills them by graft rejection. Which means they won't work.
2. The stem cells take root and kill the recipient's stem cells by 'graft versus host disease'. Without immunosuppression that is often fatal, so not so good either.

There is a third alternative of a one in a hundred million chance of a perfect match - in which case the new cells will be exactly the same as the ones already there - and will make no difference.

 

[forestglip]

Merged thread

REGENECYTE cord blood cell therapy in post-COVID syndrome: a phase IIa randomized, placebo-controlled trial

Spoiler: Authors

Huang, Yen-Wen; Chen, Ying-Chieh; Lun Lau, Ernest Yin; Su, Yu-Chin; Tai, Lung-Kuo; Rosenthal, Joseph; Wang, Jonas; Lee, Tong-Young

[Line breaks added]

Background
Post-COVID syndrome affects a substantial proportion of individuals worldwide and imposes significant healthcare and economic burdens. Fatigue is one of the most common and debilitating symptoms in those with severe symptoms related to post-COVID fatigue syndrome, yet there remains a lack of targeted therapies, effective or approved treatments to address it.

This study aimed to evaluate the safety, tolerability, and efficacy of repeated doses of REGENECYTE, an allogeneic hematopoietic progenitor cell (HPC) therapy derived from cord blood, in patients with post-COVID syndrome.

Methods
In this randomized, single-blind, placebo-controlled, phase IIa trial, we evaluated repeated intravenous infusions of REGENECYTE from different donors (without HLA matching) in patients with post-COVID syndrome in the USA. Eligible adults aged 18–65 years had persistent post-COVID symptoms between 6 and 18 months and tested negative for SARS-CoV-2 within 7 days before enrollment.

Participants were randomized into a 2:1 ratio to receive either REGENECYTE or placebo. Three infusions were administered over 6 weeks, 3 weeks apart, followed by a 20-week follow-up.

Each dose of REGENECYTE contains at least 1 × 107 total nucleated cells (TNC)/kg, with a cumulative dose of at least 3 × 107 TNC/kg per patient.

The primary endpoint was safety, assessed using the Common Terminology Criteria for Adverse Events by National Cancer Institute (NCI CTCAE) v5.0. The key secondary endpoint focused on changes in fatigue using the Chalder Fatigue Questionnaire (CFQ-11), while exploratory endpoints evaluated frailty, quality of life, and cognition using validated instruments.

This trial was registered with ClinicalTrials.gov, NCT05682560.

Findings
Between May 4 and Dec 26, 2023, 30 eligible patients were enrolled and completed the study. The mean age was 41.9 years; 70% were female. The average duration of post-COVID symptoms was 306 days.

Only 2 patients (10%) in the REGENECYTE group experienced mild treatment-emergent adverse events (TEAEs), indicating good tolerability.

Notably, REGENECYTE significantly and sustainably improved fatigue symptoms, as measured by CFQ-11 Bimodal and Likert scores, compared to placebo (p < 0.01). Improvements were observed as early as week 6 and persisted through the 20-week follow-up.

The most pronounced benefit was seen in the physical fatigue domain. REGENECYTE also improved quality of life in domains such as usual activities and mental wellbeing.

There were no significant changes in frailty or cognitive scores.

Interpretation
REGENECYTE was well tolerated and safe when administered as repeat infusions from unmatched cord blood donors. It produced a meaningful and durable reduction in fatigue symptoms, the most burdensome feature of post-COVID syndrome—highlighting its potential as a novel therapeutic strategy.

These findings support further clinical development of cord blood-based therapies targeting fatigue in post-COVID and potentially other fatigue-related conditions.

Web | DOI | PDF | eClinicalMedicine | Open Access

 

[V.R.T.]

They say fatigue not PEM which is a red flag

Any chance this is a real effect?

 

[Eleanor]

Little or no change in quality of life measures across the 6 months (see graphs) suggests the improvement in fatigue scores is an artifact of the Chalder fatigue questionnaires.

 

[forestglip]

They say fatigue not PEM which is a red flag

Why a red flag if they're studying patients with fatigue-associated long COVID, not necessarily PEM LC? My understanding/sense is that there are many with fatigue due to LC but they don't necessarily have PEM.

 

[Utsikt]

There is no assessment of the blinding. They also did not blind the people involved in the study.

CFQ-11:

Likert scores also improved significantly, decreasing from a baseline mean of 17.8 to 10.6 at week 26 in the REGENECYTE group, compared with a reduction from 18.9 to 15.9 in the placebo group (p = 0.001 at week 26; Fig. 2b).

The R group has a reduction of 7.2 points. The placebo group had a reduction of 3 points. The between group difference is 4.2 points, and the MCID is usually about 3-4 points.

With what appears to be smaller differences for the other measurements, this doesn’t look very promising to me.

If they are planning future studies they need to include objective measurements of activity, like step count, proper blinding of all involved and assessment of how successful the blinding was.

 

[Dude]

Positive Phase 2a Trial Supports FDA Clearance of StemCyte’s HPC Therapy for Long COVID Patients | Pharmacy Times

RegeneCyte's HPC therapy shows promise in treating long COVID symptoms, with 85% of patients reporting fatigue relief.

www.pharmacytimes.com

• RegeneCyte, an allogeneic cord blood-derived therapy, is approved for long COVID, showing potential in restoring blood and immune function.
• A phase 2a study showed 85% of long COVID patients experienced complete fatigue relief with RegeneCyte, compared to 20% with placebo.

 

[lelelemonade]

Perhaps to explain the absurdity of this a bit more:
If these cells are supposed to be 'regenerative' there are two possibilities.

But then, how do they even rationalize allowing stem cell trials? How do they think it works?

 

[Stuart79]

While I understand there is a plethora of of nonsense surrounding stem cell treatments, I wouldn’t be so quick to dismiss this one. It seems to work on FIP in cats, which is purported to be similar to Covid.

Mesenchymal stem/stromal cell therapy improves immune recovery in a feline model of severe coronavirus infection - PMC

Severe coronavirus infections, including SARS-CoV-2, are marked by systemic inflammation, T-cell exhaustion, lymphopenia, and chronic immune dysfunction, with limited therapeutic options for recovery. Feline infectious peritonitis (FIP), a naturally ...

pmc.ncbi.nlm.nih.gov

 

[Jonathan Edwards]

It seems to work on FIP in cats,

But is that study any good? The abstract gives us no usable data and the combination approach looks distinctly disingenuous to me.

 

[V.R.T.]

Could stem cells somehow reset an erroneous immune signalling loop or replace bad immune cells?

 

[Jonathan Edwards]

Could stem cells somehow reset an erroneous immune signalling loop or replace bad immune cells?

I cannot think of any reason why they should.

 

[Jonathan Edwards]

But then, how do they even rationalize allowing stem cell trials? How do they think it works?

I think we have to appreciate that in the last ten to twenty years, in some parts of the world, very much including the USA, any formal distinction between medical science and either crackpot ventures, or fraud, or both has disappeared. Things have changed out of all recognition. Just as people have talked of countries becoming banana republics we now have banana medicine.

In amongst that there are units delivering treeatments based on excellent science and reliable clinical evidence but even in the UK I sense my colleagues involved in medicine are beginning to lose the will to do things properly. At least for the moment populism has won.

 

[Sasha]

In amongst that there are units delivering treeatments based on excellent science and reliable clinical evidence but even in the UK I sense my colleagues involved in medicine are beginning to lose the will to do things properly. At least for the moment populism has won.

I hope that one day soon there'll be a massive backlash against all this harmful rubbish. Maybe we can spearhead it, which will unfortunately be probably once we've got a treatment, not before...

 

[Jaybee00]

I hope that one day soon there'll be a massive backlash against all this harmful rubbish.

Happening right now—google Peter Attia. He is getting dumped on for the main thing in the news, but also a result of being in the news, people are criticizing his bogus longevity claims.

Here is Topol attacking Attia:



“ Good that you posted a response, Peter. Agree, there is no defense for the now public and egregious interactions you had with Epstein.
But the man you are today vs 10 years ago has not changed w/r to arrogance. Moreover, these days you are riddled with conflicts as a huckster for David Bars, AG-1 supplement, and so many other things that diminish your credibility. That's a shame.”

But arguing myself now, if this main thing in the news didn’t come out, he was about to be hired as a health correspondent for a major U.S. TV network.