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

NCT02997878 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-07-11

No results posted yet for this study

Summary

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™.

Conditions

  • Cholangitis, Sclerosing
  • Hepatitis, Autoimmune

Interventions

BIOLOGICAL

Orbcel-C

Selected Mesenchymal Stromal Cells derived from human umbilical cord

Sponsors & Collaborators

  • NHS Blood and Transplant

    collaborator OTHER_GOV

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Phillip N Newsome, Prof · University of Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2023-11-23
Completion
2025-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02997878 on ClinicalTrials.gov