Trial Report Human Umbilical Cord Blood Infusion - Successful Phase 2a trial

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

 

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.

 

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.

 

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

 

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

 

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.