NCT02997878 (Merlin) is a Phase 1, PHASE2 clinical trial of Orbcel-C in Cholangitis, Sclerosing, sponsored by University of Birmingham.

Who is sponsoring NCT02997878?

NCT02997878 is sponsored by University of Birmingham.

What drugs are being tested in NCT02997878?

Interventions in NCT02997878: Orbcel-C.

What condition does NCT02997878 study?

NCT02997878 studies Cholangitis, Sclerosing, Hepatitis, Autoimmune.

Is NCT02997878 still recruiting?

NCT02997878 is currently active, enrolled. Last updated 11 July 2024.

Last reviewed 2024-07-11 · How we verify

NCT02997878: Merlin

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

Selected Mesenchymal Stromal Cells to Reduce Inflammation in Patients With PSC and AIH

Active, enrolled Phase 1, PHASE2 Last updated 11 July 2024

What this trial tests

Phase 1, PHASE2 trial testing Orbcel-C in Cholangitis, Sclerosing in 18 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 December 2018

Primary endpoint
23 November 2023

1 October 2025

Quick facts

Lead sponsor	University of Birmingham
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	7 December 2018
Primary completion	23 November 2023
Estimated completion	1 October 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

Orbcel-C — full drug profile →

Conditions studied

Cholangitis, Sclerosing — all drugs for Cholangitis, Sclerosing →
Hepatitis, Autoimmune — all drugs for Hepatitis, Autoimmune →

Sponsor

University of Birmingham

Who can join

18 and older, any sex, with Cholangitis, Sclerosing or Hepatitis, Autoimmune. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

MERLIN is an adaptive, single arm, multi-centre, phase IIa multi-disease clinical trial. It is designed to: i) Determine dose safety of ORBCEL-C™ (selected Mesenchymal stromal cells derived from human umbilical cord) ii) Evaluate treatment activity through assessment of biomarkers (for patients treated at the highest safe dose only (HSD)) This trial will determine the Highest Safe Dose (HSD) that can be administered by observing for occurrence of dose limiting toxicity (DLT). Upon completion of this trial we hope to be able to justify and conduct separate, larger scale trials using ORBCEL-C™.

Publications & conference data

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

Mesenchymal Stem/Stromal Cells for Rheumatoid Arthritis Treatment: An Update on Clinical Applications.
Lopez-Santalla M, Fernandez-Perez R, Garin MI. · · 2020 · cited 98× · PMID 32784608 · DOI 10.3390/cells9081852
Clinical management of autoimmune hepatitis.
Pape S, Schramm C, Gevers TJ. · · 2019 · cited 58× · PMID 31700628 · DOI 10.1177/2050640619872408
Primary sclerosing cholangitis.
Rabiee A, Silveira MG. · · 2021 · cited 40× · PMID 33824933 · DOI 10.21037/tgh-20-266
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
Towards the standardization of methods of tissue processing for the isolation of mesenchymal stromal cells for clinical use.
García-Muñoz E, Vives J. · · 2021 · cited 20× · PMID 33994662 · DOI 10.1007/s10616-021-00474-3
Autoimmune hepatitis: Current and future therapies.
Reau NS, Lammert CS, Weinberg EM. · · 2024 · cited 19× · PMID 38836863 · DOI 10.1097/hc9.0000000000000458
The Management of Cholestatic Liver Diseases: Current Therapies and Emerging New Possibilities.
Mazzetti M, Marconi G, Mancinelli M, Benedetti A, et al · · 2021 · cited 17× · PMID 33919600 · DOI 10.3390/jcm10081763
Mesenchymal stem cells-based therapy in liver diseases.
Han HT, Jin WL, Li X. · · 2022 · cited 14× · PMID 35895169 · DOI 10.1186/s43556-022-00088-x

Verify or expand the search:

Other recruiting trials for Cholangitis, Sclerosing

Currently open trials in the same condition.

NCT06864195 — A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions · recruiting
NCT04181138 — Primary Sclerosing Cholangitis in Children · recruiting
NCT03146936 — Swiss Primary Sclerosing Cholangitis Cohort Study · recruiting

Other University of Birmingham trials

Trials by the same sponsor.

NCT07160686 — Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment · Phase 3 · not yet recruiting
NCT07446166 — TETANUS Antibody Detection in Saliva Study · NA · not yet recruiting
NCT07294794 — Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension · NA · not yet recruiting
NCT07246356 — Feasibility and Efficacy of GTEP for Birth Trauma · NA · recruiting
NCT06932653 — Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial · 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 NCT02997878 (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 University of Birmingham
Last refreshed: 11 July 2024

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/NCT02997878.

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