MSCs from Amniotic Membrane
The most-studied cell type in the field — and the one whose late-phase record is most sobering.
Investigational
What it actually is
Mesenchymal stromal cells from the amniotic membrane of the placenta are plastic-adherent, spindle-shaped cells defined by a surface-marker panel rather than by a function. They are not primarily replacement cells. Their proposed action is paracrine: they secrete cytokines, growth factors and vesicles that modulate immune activity, then they are cleared, mostly within days and mostly in the lungs after intravenous infusion.
Where it comes from
Allogeneic, from donated placental tissue after consented full-term delivery. Perinatal tissue is otherwise discarded, is available in volume, and yields cells that proliferate faster than adult bone-marrow MSCs. One donation can supply many doses, which is why allogeneic perinatal MSCs dominate the commercial pipeline.
How it is made — and what can go wrong
Tissue is dissected, digested and the adherent fraction expanded through several passages, then cryopreserved in doses. Two things drive product variability more than anything else: the donor, and cryopreservation. Freeze-thaw can transiently blunt the very immunomodulatory function the product is sold on. This is a known and published problem, not a theoretical one.
Regulatory status
Alofisel (darvadstrocel), an allogeneic expanded adipose MSC product, was authorised in the EU in March 2018 for complex perianal fistulas in Crohn's disease. In October 2023 its confirmatory phase 3 trial, ADMIRE-CD II, in 568 patients, missed its primary endpoint. The European Commission withdrew the marketing authorisation on 13 December 2024. Anyone presenting MSC therapy as settled medicine should be asked to account for that sequence.
What the evidence shows
MSC products are consistently safe across large numbers of infusions. Efficacy is where the field struggles, and the reason is measurable: there is no validated potency assay. Regulators state plainly that the mechanism is not resolved to a pathway, so developers each define their own critical quality attributes. Two products both correctly called 'MSC' can be biologically different.
Limits worth knowing
Donor-to-donor variability is unpredictable — responsiveness to interferon-gamma differs between donors, and no steady-state surface marker predicts it. A product that worked in one trial says little about a differently manufactured product with the same name.
What this could actually be used for
The name misleads. Mesenchymal stromal cells rarely become the tissue they are injected into, and most do not survive long after injection. What they do reliably, while alive, is secrete — growth factors, anti-inflammatory mediators, vesicles — and reprogramme the immune cells around them.
So the interest is not replacing tissue but changing the local environment: damping inflammation, supporting blood vessels, shifting an immune response from destructive to reparative. That explains both the breadth of the field and its inconsistency — the same mechanism is plausible almost everywhere and decisive almost nowhere.
Autoimmune and inflammatory disease 57 studies registered
Perianal fistulas in Crohn disease are where this reached an authorised European medicine, and the reason is instructive: a local, contained, inflammation-driven problem, treated by injecting cells directly into the tract rather than hoping they find it from the bloodstream. All cell therapy research registered for this condition →
Joints 129 studies registered
By far the largest research area. The proposed mechanism is anti-inflammatory and trophic — the joint hurts less because the inflammatory environment changes — not cartilage regrowth. Marketing routinely blurs those two, and they imply completely different expectations about how long any effect should last. All cell therapy research registered for this condition →
Graft-versus-host disease
Immune modulation applied to a life-threatening complication after bone marrow transplant, where the donor immune system attacks the recipient. This is the setting where the immunological mechanism is least speculative, because suppressing a runaway immune response is exactly what these cells are proposed to do.
Liver, lung and kidney fibrosis 64 studies registered
Organs where scarring follows chronic inflammation. The step being targeted is the cycle itself — interrupting inflammation before it lays down more scar — rather than removing fibrosis that already exists. All cell therapy research registered for this condition →
Wound healing and vascular support 113 studies registered
In poorly perfused tissue the proposed contribution is signalling that supports new small vessels, which is why diabetic foot ulcers and critical limb ischaemia appear repeatedly in the registry. All cell therapy research registered for this condition →
Where it stops. ‘MSC’ covers preparations from bone marrow, fat, cord and placenta, at different passages and potencies, and they are not interchangeable. Registries do not separate them and neither do most published claims — so a count of MSC studies is not evidence for any one product.
What the registry actually shows for this cell type
Our own count of every study registered on ClinicalTrials.gov under this cell type, retrieved 2026-09-04. A registration is a declaration of intent, not a result — which is why the status column matters more than the total does.
| Status in the registry | Studies | Share |
|---|---|---|
| Completed | 619 | 34% |
| Status not updated by sponsor | 585 | 32% |
| Recruiting now | 186 | 10% |
| Not yet recruiting | 144 | 8% |
| Withdrawn before enrolling | 84 | 5% |
| Terminated early | 83 | 5% |
| Active, closed to entry | 69 | 4% |
| No longer available | 25 | 1% |
| Suspended | 23 | 1% |
| Enrolling by invitation only | 12 | 1% |
| Expanded access | 7 | 0% |
| All registered studies | 1837 | 100% |
Reading it: 190 studies stopped before finishing — terminated, withdrawn or suspended, 10% of the total; 317 studies carry no assigned trial phase, meaning they sit outside the phased development path that leads to an approved medicine; 438 studies reached Phase 2 or later, against 1082 studies still at Phase 1 or earlier; 585 records have not had a status update from the sponsor and may be dormant.
The directions above describe where the biology points and where research has been registered. They are not claims that any of it works, not evidence of benefit, and not a treatment recommendation. Counts are our own extraction from the ClinicalTrials.gov API, retrieved 2026-09-04; the queries behind them are published with the dataset so that anyone can repeat the count.
What to ask before agreeing to anything
- Which tissue, which donor screening, which passage number, and how many doses per donation?
- What potency assay is used for release — and is it functional, or only a marker panel?
- Fresh or cryopreserved at the point of administration, and what post-thaw viability is released?
- Which specific trial supports this indication, using a product manufactured the same way?
Sources behind the numbers on this page
- PubMed — MSCs from Amniotic Membrane
- ClinicalTrials.gov — registered studies
- EMA — advanced therapy medicinal products
- FDA — cellular and gene therapy products
Study counts above are our own extraction from ClinicalTrials.gov; the links let you reproduce them. Not medical advice, and not an assessment of whether any treatment is appropriate for you.