NCT04548583 is a Phase 1, PHASE2 clinical trial of Remestemcel-L in Crohn Colitis, sponsored by The Cleveland Clinic.

Who is sponsoring NCT04548583?

NCT04548583 is sponsored by The Cleveland Clinic.

What drugs are being tested in NCT04548583?

Interventions in NCT04548583: Remestemcel-L, Remestemcel-L, Placebo.

What condition does NCT04548583 study?

NCT04548583 studies Crohn Colitis.

Is NCT04548583 still recruiting?

NCT04548583 is currently terminated. Last updated 16 April 2026.

Last reviewed 2026-04-16 · How we verify

NCT04548583

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

Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis

Terminated Phase 1, PHASE2 Last updated 16 April 2026

What this trial tests

Phase 1, PHASE2 trial testing Remestemcel-L in Crohn Colitis in 7 participants. Terminated before completion.

Timeline

4 November 2020

Primary endpoint
15 November 2023

15 November 2023

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	7
Start date	4 November 2020
Primary completion	15 November 2023
Estimated completion	15 November 2023
Sites	1 location across United States

Drugs / interventions tested

Remestemcel-L — full drug profile →
Remestemcel-L — full drug profile →
Placebo

Conditions studied

Crohn Colitis — all drugs for Crohn Colitis →

Sponsor

The Cleveland Clinic

Who can join

Adults 18 to 75, any sex, with Crohn Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Crohn's disease has several phenotypes (inflammatory, stricturing, fistulizing) and location (small bowel, ileocecal, colon, and perianal). Approximately one third of patients have inflammation limited to the colon. Up to two thirds will become medically refractory and require a total abdominal colectomy for symptom control. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory Crohn's colitis.

Publications & conference data

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

Therapeutic potential of mesenchymal stem/stromal cells (MSCs)-based cell therapy for inflammatory bowel diseases (IBD) therapy.
Saadh MJ, Mikhailova MV, Rasoolzadegan S, Falaki M, et al · · 2023 · cited 45× · PMID 36707899 · DOI 10.1186/s40001-023-01008-7
Mesenchymal stem cells in treating human diseases: molecular mechanisms and clinical studies.
Han X, Liao R, Li X, Zhang C, et al · · 2025 · cited 34× · PMID 40841367 · DOI 10.1038/s41392-025-02313-9
The Clinical Trials of Mesenchymal Stromal Cells Therapy.
Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
Human Mesenchymal Stem/Stromal Cells in Immune Regulation and Therapy.
Mezey É. · · 2022 · cited 28× · PMID 35298659 · DOI 10.1093/stcltm/szab020
Mesenchymal stem/stromal cells in the pathogenesis and regenerative therapy of inflammatory bowel diseases.
Che Z, Ye Z, Zhang X, Lin B, et al · · 2022 · cited 25× · PMID 35990688 · DOI 10.3389/fimmu.2022.952071
Stem cell transplantation for induction of remission in medically refractory Crohn's disease.
El-Nakeep S, Shawky A, Abbas SF, Abdel Latif O. · · 2022 · cited 11× · PMID 35556242 · DOI 10.1002/14651858.cd013070.pub2

Verify or expand the search:

Other trials of Remestemcel-L

Trials testing the same drug.

NCT04543994 — Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC) · Phase 1, PHASE2 · terminated
NCT04371393 — MSCs in COVID-19 ARDS · Phase 3 · terminated
NCT02652130 — Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatme · Phase 3 · completed
NCT04456439 — Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome i · no longer available
NCT04366830 — Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory Distress Syndrome · no longer available

Other The Cleveland Clinic trials

Trials by the same sponsor.

NCT07218198 — Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension · NA · not yet recruiting
NCT07442747 — Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS · NA · not yet recruiting
NCT07471464 — Centered Surgery - Preoperative Counseling and Patient Satisfaction · recruiting
NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
NCT07363343 — Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study · NA · not yet 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 NCT04548583 (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 The Cleveland Clinic
Last refreshed: 16 April 2026

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/NCT04548583.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing