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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

NCT01233960

Crohn's Disease

COMPLETED PHASE3

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

NCT00543374

Crohn's Disease

COMPLETED PHASE3

Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

NCT00482092

Crohn's Disease

COMPLETED PHASE3

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

NCT00294112

Crohn's Disease

COMPLETED PHASE2

Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis

NCT04548583

Crohn Colitis

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PROCHYMAL (remestemcel-L)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* currently active moderate-to-severe Crohn's disease
* exhausted standard-of-care options
* age 18 to 70 inclusive
* body weight between 30 and 150 kg
* adequate renal function
* not at risk for tuberculosis (TB) activation or re-activation

Exclusion Criteria

* biologic therapy for Crohn's within last 8 weeks
* confirmed adverse reactions during prior PROCHYMAL study participation
* alcohol or substance abuse, current or within past 6 months
* active HIV or hepatitis B or C infection
* surgery or trauma with 6 weeks
* allergy to bovine or porcine products
* elevated serum liver enzymes
* elevated serum bilirubin
* active malignancy within 5 years (other than some resected skin cancers)
* bacteremia or other serious bacterial or fungal infection within 3 months
* colonic dysplasia
* unstable arrhythmia or serious heart condition

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No