NCT03631589 is a Phase 2, PHASE3 clinical trial of MSCs in Steroid-resistant Severe aGVHD, sponsored by Fujian Medical University.

Who is sponsoring NCT03631589?

NCT03631589 is sponsored by Fujian Medical University.

What drugs are being tested in NCT03631589?

Interventions in NCT03631589: MSCs.

What condition does NCT03631589 study?

NCT03631589 studies Steroid-resistant Severe aGVHD.

Is NCT03631589 still recruiting?

NCT03631589 is currently status unknown. Last updated 15 August 2018.

Last reviewed 2018-08-15 · How we verify

NCT03631589

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

MSC for Severe aGVHD

Status unknown Phase 2, PHASE3 Last updated 15 August 2018

What this trial tests

Phase 2, PHASE3 trial testing MSCs in Steroid-resistant Severe aGVHD in 50 participants. Status unknown.

Timeline

1 December 2017

Primary endpoint
1 December 2019

1 December 2021

Quick facts

Lead sponsor	Fujian Medical University
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 December 2017
Primary completion	1 December 2019
Estimated completion	1 December 2021
Sites	1 location across China

Drugs / interventions tested

MSCs — full drug profile →

Conditions studied

Steroid-resistant Severe aGVHD — all drugs for Steroid-resistant Severe aGVHD →

Sponsor

Fujian Medical University

Who can join

Under 65, any sex, with Steroid-resistant Severe aGVHD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Cell therapies in the clinic.
Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
Clinical Use of Mesenchymal Stromal Cells in the Treatment of Acute Graft-versus-Host Disease.
Elgaz S, Kuçi Z, Kuçi S, Bönig H, et al · · 2019 · cited 58× · PMID 31244579 · DOI 10.1159/000496809
Prevention and Treatment of Acute Graft-versus-Host Disease in Children, Adolescents, and Young Adults.
Gatza E, Reddy P, Choi SW. · · 2020 · cited 41× · PMID 31931115 · DOI 10.1016/j.bbmt.2020.01.004
Human Mesenchymal Stem/Stromal Cells in Immune Regulation and Therapy.
Mezey É. · · 2022 · cited 28× · PMID 35298659 · DOI 10.1093/stcltm/szab020
Extracellular vesicles: a new frontier in diagnosing and treating graft-versus-host disease after allogeneic hematopoietic cell transplantation.
Wu P, Wang Z, Sun Y, Cheng Z, et al · · 2025 · cited 5× · PMID 40133949 · DOI 10.1186/s12951-025-03297-y
The roles and clinical applications of mesenchymal stem cells and their exosomes in hematologic diseases.
Deng M, Zhang X, Zhang Y. · · 2025 · PMID 41444972 · DOI 10.1186/s13287-025-04880-8

Verify or expand the search:

Other trials of MSCs

Trials testing the same drug.

NCT07465198 — Autologous Stem Cell Therapy in Patients With Multiple System Atrophy · Phase 2 · not yet recruiting
NCT07240987 — Mesenchymal Stem Cells for Chronic Kidney Diseases · Phase 1, PHASE2 · not yet recruiting
NCT04749667 — Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis · Phase 1, PHASE2 · active not recruiting

Other Fujian Medical University trials

Trials by the same sponsor.

NCT07314203 — Clinical Efficacy of Adebrelimab With or Without Apatinib Mesilate and SOX Neoadjuvant Therapy in Locally Advanced Gastr · Phase 3 · not yet recruiting
NCT07491263 — Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Le · Phase 1 · not yet recruiting
NCT07275034 — A Virtual Reality-Based Horticultural Planting Program for Elderly With Subthreshold Depression · NA · not yet recruiting
NCT07383909 — Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery · NA · recruiting
NCT07419932 — Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03631589 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fujian Medical University
Last refreshed: 15 August 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03631589.

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