Evidence map›Paper›PMID 38804990›Full record

ReviewCytotherapy2024

International Society for Cell and Gene Therapy Clinical Translation Committee recommendations on mesenchymal stromal cells in graft-versus-host disease: easy manufacturing is faced with standardizing and commercialization challenges.

Abdulrahman Alsultan, Dominique Farge, Sven Kili, Miguel Forte, Daniel J Weiss, Felix Grignon, Jaap Jan Boelens

Abstract readReview
In one paragraph

Review in Cytotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Abdulrahman AlsultanDepartment of Pediatrics, College of Medicine, King Saud University, Riyadh, Saudi Arabia; Transplantation and Cellular Therapy, MSK Kids, Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Dominique FargeInternal Medicine Unit (UF 04): CRMR MATHEC, Autoimmune diseases and Cellular Therapy, St-Louis Hospital, Center of reference for rare systemic autoimmune diseases of Ile-de-France (FAI2R), AP-HP, Hôpital St-Louis, Paris University, IRSL, Paris, France; Department of Medicine, McGill University, Montreal, Quebec, Canada.
Sven KiliSven Kili Consulting Ltd., Shrewsbury, UK; Saisei Ventures, Boston, Massachusetts, USA; CCRM, Toronto, Canada.
Miguel ForteKiji Therapeutics, Paris, France.
Daniel J WeissUniversity of Vermont College of Medicine, Burlington, Vermont, USA.
Felix GrignonInternational Society for Cell & Gene Therapy, Vancouver, Canada.
Jaap Jan BoelensTransplantation and Cellular Therapy, MSK Kids, Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York, USA. Electronic address: boelensj@mskcc.org.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Mesenchymal stromal cells (MSCs) have been used in multiple clinical trials for steroid-refractory moderate-severe (grade II-IV) acute graft-versus-host disease (aGVHD) across the world over the last two decades. Despite very promising results in a variety of trials, it failed to get widespread approval by regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency. What lessons can we learn from this for future studies on MSCs and other cell therapy products? Broad heterogeneity among published trials using MSCs in aGVHD was likely the core problem. We propose a standardized approach in regards to donor-related factors, MSCs-related characteristics, as well as clinical trial design, to limit heterogeneity in trials for aGVHD and to fulfill the requirements of regulatory agencies. This approach may be expanded beyond MSCs to other Cell and Gene therapy products and trials in other diseases.

Indexed as

Graft vs Host DiseaseMesenchymal Stem CellsMesenchymal Stem Cell TransplantationCell- and Tissue-Based TherapyClinical Trials as TopicGenetic TherapyHumansGVHDhematopoietic cell transplantationISCTMSCs

Identifiers

PMID38804990
PMCPMC12046531

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.