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NCT00294112 · ClinicalTrials.gov registry record · Phase 2

Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease

A Phase 2 study, sponsored by Mesoblast.

Completed
Registry status
Phase 2
Development phase
10
Enrollment target

NCT00294112: Completed Phase 2 study, sponsored by Mesoblast.

NCT00294112 is a Phase 2 study that has completed, run by Mesoblast. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00294112, a Phase 2 study, has completed, sponsored by Mesoblast.

COMPLETED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

Human mesenchymal stem cells (MSCs), derived from healthy adult volunteer human donors, can be obtained from bone marrow donation and cultured in the laboratory. MSCs have shown the ability to find injured tissue, reduce and control inflammation, and assist in tissue repair. Prochymal™ MSCs will be infused into patients with moderate-to-severe Crohn's disease. Infusions will occur on two separate days, 7-10 days apart. Patients will be monitored for reduced Crohn's disease symptoms.

Primary Outcome

The CDAI is a composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more disease activity.

Interventions

  • DRUG Prochymal™ adult human mesenchymal stem cells
  • DRUG adult human mesenchymal stem cells

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2006-03-13
Est. Completion 2006-07-21
Phase Phase 2
Mesoblast

25 total trials

What the finished NCT00294112 record still lists

NCT00294112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Prochymal™ adult human mesenchymal stem cells is the first listed.

NCT00294112 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00294112 about?

NCT00294112 is a clinical study titled "Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease". Human mesenchymal stem cells (MSCs), derived from healthy adult volunteer human donors, can be obtained from bone marrow donation and cultured in the laboratory. MSCs have shown the ability to find injured tissue, reduce and control inflammation, and assist in tissue repair. Prochymal™ MSCs will be...

What is the current status of trial NCT00294112?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2006-03-13. Estimated completion is 2006-07-21.

What interventions are being tested in trial NCT00294112?

The interventions under investigation include: Prochymal™ adult human mesenchymal stem cells (DRUG), adult human mesenchymal stem cells (DRUG).

Who is sponsoring clinical trial NCT00294112?

This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00294112's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00294112, the US trial registry maintained by the National Library of Medicine. NCT00294112 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.