Trials / No Longer Available
No Longer AvailableNCT01510431
Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Mesoblast, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | PROCHYMAL (remestemcel-L) | intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter |
Timeline
- First posted
- 2012-01-16
- Last updated
- 2020-03-10
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01510431. Inclusion in this directory is not an endorsement.