CompletedPhase 3

Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

United States98 participantsStarted 2007-09-17

Plain-language summary

Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28 Exclusion Criteria: * Substance abuse * Failure to receive full dose of all interventions in Protocol 603

What they're measuring

Duration of clinical benefit (Crohn's disease activity index)

Timeframe: 6 months

Re-induction of clinical benefit (Crohn's disease activity index)

Timeframe: 6 months

Trial details

NCT IDNCT00543374

SponsorMesoblast, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-07

View on ClinicalTrials.gov More Crohn's Disease trials