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

A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00543374

Enrollment

Registered

2007-10-15

Start date

2007-09-17

Completion date

2011-04-28

Last updated

2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief 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.

Detailed description

A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment. PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic. Protocol 610 is an extension study offered only to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.

Interventions

DRUGPlacebo

DRUGPROCHYMAL adult human mesenchymal stem cells

intravenous infusion four times over two weeks; possibly repeated once

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Duration of clinical benefit (Crohn's disease activity index)	6 months
Re-induction of clinical benefit (Crohn's disease activity index)	6 months

Secondary

Measure	Time frame
Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)	6 months

Countries

Canada, United States

Contacts

STUDY_DIRECTORChristopher James, PA

Mesoblast, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026