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Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

NCT01510431 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2020-03-10

No results posted yet for this study

Summary

Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.

The study is not placebo-controlled or randomized.

Conditions

Interventions

DRUG

PROCHYMAL (remestemcel-L)

intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter

Sponsors & Collaborators

  • Mesoblast, Inc.

    lead INDUSTRY

Principal Investigators

  • Mahboob Rahman, MD · Mesoblast, Inc.

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01510431 on ClinicalTrials.gov