Overview

Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease

Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the safety and efficacy of using adult allogeneic bone marrow derived mesenchymal stem cells (MSCs), to treat people for medically refractory perianal fistulizing Crohn's disease.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amy Lightner
The Cleveland Clinic
Criteria
Inclusion Criteria

1. Men and Women 18-75 years of age with a diagnosis of Crohn's disease for at least six
months duration.

2. Single and Multi-tract Perianal fistula, with or without previous failed surgical
repair.

3. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active
metal fragments, claustrophobia

4. Ability to comply with protocol

5. Competent and able to provide written informed consent

6. Concurrent Crohn's-related therapies with stable doses corticosteroids, 5- ASA drugs,
immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are
permitted.

Exclusion Criteria

1. Inability to give informed consent.

2. Clinically significant medical conditions within the six months before administration
of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other
conditions that would, in the opinion of the investigators, compromise the safety of
the patient.

3. Specific exclusions:

1. Hepatitis B or C

2. HIV

3. Abnormal AST or ALT at screening

4. History of cancer including melanoma (with the exception of localized skin cancers) in
the past five years

5. Investigational drug within one month of treatment

6. Pregnant or breast feeding or trying to become pregnant.

7. Presence of a rectovaginal or perineal body fistula

8. Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment

9. Uncontrolled intestinal Crohn's disease which will require escalation for medical
therapy or surgery within 2 months of enrollment

10. Severe anal canal disease that is stenotic and requires dilation

11. Currently taking corticosteroids

12. Female participant unwilling to agree to use acceptable contraception methods during
participation in study

13. Allergy to DMSO