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Crohn's DiseasePhase 2NCT00294112

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

A Phase 2 study testing Prochymal™ adult human mesenchymal stem cells and adult human mesenchymal stem cells in people with Crohn's Disease, run by Mesoblast, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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™ adult human mesenchymal stem cells and adult human mesenchymal stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesUnited States
Study dates
13 Mar 2006to 21 Jul 2006
Phase
Phase 2
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

  • Subject must be 18 to 70 years of age, inclusive.
  • If female and of child-bearing age, subject must be non-pregnant, non-breast-feeding, and use adequate contraception. If male, subject must use adequate contraception.
  • Subject must have endoscopically or radiographically active Crohn's disease
  • Subject must have a Crohn's disease activity index (CDAI) of at least 220.
  • Subject must have a C-reactive protein (CRP) of at least 5 mg/l.
  • Subject must have ileocolitis, colitis, or ileitis.
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  • At some time during the course of the subject's Crohn's disease (CD), subject must have received both steroids and immunosuppressive agents (for example, azothioprine, 6-mercaptopurine, or methotrexate) which did not control the CD.
  • Subject may be receiving antibiotics, 5-aminosalicylic acid, azathioprine, 6-mercaptopurine, methotrexate, prednisone, or any similar drugs at the time of enrollment.
  • The dose of 5-aminosalicylic acid (5-ASA) must have been stable for at least 4 weeks prior to enrollment.
  • The dose of steroids must have been stable for at least 4 weeks prior to enrollment.
  • The dose of antibiotics must have been stable for at least 4 weeks prior to enrollment.
  • The dose of immunosuppressants (for example, azathioprine, 6-mercaptopurine [6-MP], or methotrexate) must have been stable for at least 8 weeks prior to enrollment and the subject on therapy for at least three months prior to enrollment.
  • Subject must have adequate renal function as defined by a calculated creatinine clearance of greater than 30 ml/min using the Cockcroft-Gault equation, and a serum creatinine concentration of less than 2.0 mg/dl.
  • Subject must be available for all specified assessments at the study site through day 30.
  • Subject must provide a written informed consent form (ICF) and authorization for use of and disclosure of personal health information (PHI).

Who cannot join

  • Subject has any alcohol or substance abuse within 6 months of randomization.
  • Subject has evidence of fibrostenotic obstructive Crohn's disease.
  • Subject has an active infection with HIV or hepatitis B or C.
  • Subject has had surgery or trauma within 28 d prior to enrollment.
  • Subject has a known allergy to computed tomography (CT) contrast agents.
  • Subject has a known allergy to bovine or porcine products.
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  • Subject has body mass greater than 150 kg.
  • Subject has had a stricture of the bowel requiring hospitalization within 6 months prior to enrollment.
  • Subject has had bowel surgery other than perianal (for example, fistulotomy, seton placement, or abscess drainage) within 6 months prior to enrollment.
  • Subject has received infliximab; adalimumab; or other antibody, protein, or biological therapy not specifically approved by the United States Food and Drug Administration (FDA) for Crohn's disease for 90 days (d) prior to enrollment in study.
  • Subject has received prednisone greater than 20 mg/d at any time 28 d prior to enrollment in study.
  • Subject has a permanent colostomy or ileostomy.
  • Subject has aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine transaminase (ALT) more than 2.5 times the upper limit of normal at screening.
  • Subject has evidence of active malignancy other than resected basal or squamous cell carcinoma of the skin, or prior history of active malignancy that has not been in remission for at least 5 years.
  • Subject has history of bacteremia or other serious bacterial or fungal infection in past 3 months other than a treated urinary tract infection or drained perianal abscess.
  • Subject has received an investigational agent (IA)-an agent or device not approved by FDA for marketed use in any indication-within 90 d (or 5 half-lives, whichever is longer) of randomization.
  • Subject has cardiopulmonary disease that, in the opinion of the Investigator, is either unstable or severe enough to justify exclusion from this study.
  • Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would make participation in the study unsafe.
  • Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject. Such excluding conditions might include, for example, uncontrolled infection, right heart failure, pulmonary hypertension.
  • Subject has unstable arrhythmia.
  • Subject is unwilling or unable to adhere to requirements of protocols.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Osiris Clinical Site

    Baton Rouge, Louisiana, 70801

  • Osiris Clinical Site

    Charlotte, North Carolina, 28105

  • Osiris Clinical Site

    Pittsburgh, Pennsylvania, 15106

  • Osiris Clinical Site

    Richmond, Virginia, 23173

Other trials in United States

About this study

Official title: A Phase II, Open-label, Randomized Study to Evaluate the Safety and Efficacy of PROCHYMAL™ IBD (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects Experiencing Moderate-to-severe Crohn's Disease That is Refractory to Steroids and Immune Suppressants

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.

Read the detailed description

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. Patients will receive high or low dose. Study is open label.

Conditions
Crohn's Disease
Being tested
Prochymal™ adult human mesenchymal stem cells, adult human mesenchymal stem cells
Keywords
mesenchymal stem cells
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™ adult human mesenchymal stem cellsDrug

    Also called PROCHYMAL

    Cells in plasmalyte and containing dimethylsulfoxide

  • adult human mesenchymal stem cellsDrug

    Also called PROCHYMAL

    two infusions, one week apart, each comprising adult human mesenchymal stem cells

Study groups in NCT00294112
Study groupRoleWhat they receive
High doseExperimentalHigh dose (8 million cells per kg of body weight)
Receives: Drug: Prochymal™ adult human mesenchymal stem cells; Drug: adult human mesenchymal stem cells
Low doseExperimentalLow dose: 2 million cells per kg body weight
Receives: Drug: Prochymal™ adult human mesenchymal stem cells; Drug: adult human mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Reduction in Crohn's Disease Activity Index (CDAI) of at Least 100 Points

    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.

    Measured: 28 days

Secondary outcomes (9)

  1. Number of Participants with Reduction in CDAI of at Least 70 points

    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.

    Measured: 28 days

  2. Improvement as Assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)

    The IBDQ measures disease-specific quality of life by assessing bowel symptoms, systemic symptoms, emotional function, and social function. Subscores can range from 1 (worst) to 7 (best). The total IBDQ is calculated as the sum of the responses to the individual IBDQ questions. The total score ranges from 32 to 224. An increase in score from baseline indicates improvement.

    Measured: 28 days

  3. Time to Improvement in IBDQ

    Measured: 28 days

  4. Number of Participants with Reduction of at Least 50% in Fistulas in Participants with Fistulas Draining Under Moderate Compression

    Measured: 28 days

  5. Number of Participants with Induction of Remission as Defined by Reduction of CDAI to Below 150

    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.

    Measured: 28 days

  6. Time to Reduction in CDAI of at Least 100 Points

    Measured: 28 days

  7. Time to Reduction in CDAI of at Least 70 Points

    Measured: 28 days

  8. Time to Induction of Remission as Defined by Reduction of CDAI to Below 150.

    Measured: 28 days

  9. Number of Participants with Adverse Events

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2006 (estimated)
  2. Study start13 Mar 2006
  3. Primary completion21 Jul 2006
  4. Study completion21 Jul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00294112
Sponsor's protocol ID
OSIRIS-601-602
Status last verified
Mar 2020
First submitted
17 Feb 2006
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prochymal™ adult human mesenchymal stem cells and adult human mesenchymal stem cells 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 15 inclusion and 21 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: finished, as of the sponsor's last update on 2 Apr 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Number of Participants with Reduction in Crohn's Disease Activity Index (CDAI) of at Least 100 Points (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00294112.

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 2 Apr 2020.

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