Crohn's DiseaseNCT01510431
Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
A study testing PROCHYMAL (remestemcel-L) in people with Crohn's Disease, run by Mesoblast, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- PROCHYMAL (remestemcel-L)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2285
Mount Sinai Hospital
New York, New York, 10128
Unviersity of California, San Francisco
San Francisco, California, 94115
Stormont-Vail
Topeka, Kansas, 66606
About this study
Official title: 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
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
- Crohn's Disease
- Being tested
- PROCHYMAL (remestemcel-L)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROCHYMAL (remestemcel-L)Drug
intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Mesoblast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahboob Rahman, MD, Study director, Mesoblast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510431
- Sponsor's protocol ID
- CRD 620
- Status last verified
- Mar 2020
- First submitted
- 9 Jan 2012
- Last updated
- 10 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01510431
- Acronym / sponsor ID
- CRD 620
- Conditions
- Crohn's Disease
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Mesoblast, Inc.Industry (pharma, biotech, devices)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROCHYMAL (remestemcel-L)intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahboob Rahman, MD study director
Mesoblast, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROCHYMAL (remestemcel-L) in people with Crohn's Disease, run by Mesoblast, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.