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Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease (RVF)

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ClinicalTrials.gov Identifier: NCT04519697
Recruitment Status : Unknown
Verified April 2022 by Amy Lightner, The Cleveland Clinic.
Recruitment status was:  Recruiting
First Posted : August 20, 2020
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Amy Lightner, The Cleveland Clinic

Study Description
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Brief Summary:
Approximately 10% of all female Crohn's patients have a rectovaginal fistula. Rectovaginal fistulas cause air, stool, and/or drainage per vagina and may be associated with pain, recurrent urinary tract infections and diminished quality of life. Conventional therapy includes immunosuppressive medications used to treat Crohn's disease and various surgical interventions. However, all have limited ability to heal these fistulas. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with rectovaginal fistulas in the setting of Crohn's disease.

Condition or disease Intervention/treatment Phase
Rectovaginal Fistula Crohn Disease Crohn Disease of Vulva Rectolabial; Fistula Drug: Mesenchymal Stem Cells Other: Placebo Phase 1 Phase 2

Detailed Description:
This study is designed to determine the safety and efficacy of direct injection of adult allogeneic bone marrow derived mesenchymal stem cells for the treatment of rectovaginal fistulas in the setting of Crohn's disease. The study will randomize 20 participants. Enrolled participants will be randomized to treatment group with MSCs versus placebo in a 3:1 fashion. Participants in the treatment group will have a direct injection of MSCs at a dose of 75 million cells. This will be given as a direct injection in and around the fistula tract. Participants will be evaluated for complete healing at three months. If complete healing has been achieved patients will continue to be followed for one year. If complete healing has not been achieved at three months, participants will be eligible for a second injection of MSCs at the same dose of 75 million cells. Control participants without complete healing from placebo will cross over at the six month visit to receive an injection of MSCs, and will be followed for one year after treatment for a total duration of 18 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal Stem Cells
Direct injection of adult allogeneic bone marrow derived mesenchymal stem cells at a dose of 75 million cells into rectovaginal fistula at baseline with a possible repeat injection at 3 months if not completely healed from the first injection.
 Drug: Mesenchymal Stem Cells
Adult allogeneic bone marrow derived mesenchymal stem cells for the treatment of rectovaginal fistulas in the setting of Crohn's disease.
Placebo Comparator: Placebo
Direct injection of normal saline with a possible repeat injection at 3 months if not completely healed from the first injection. If not completely healed after 6 months, participants will then cross over to the treatment group to receive a direct injection of adult allogeneic bone marrow derived mesenchymal stem cells at a dose of 75 million cells into rectovaginal fistula.
 Other: Placebo
Normal Saline


Outcome Measures
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Primary Outcome Measures :
  1. Treatment related adverse events [ Time Frame: Month 6 ]
    Number of participants with treatment related adverse events post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of rectovaginal fistula in the setting of Crohn's disease as assessed by protocol CCF-Stem Cells IBD-003


Secondary Outcome Measures :
  1. Complete clinical healing [ Time Frame: Month 6, Month 12 ]

    Number of participants with complete clinical healing post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of rectovaginal fistula in the setting of Crohn's disease.

    Complete healing is defined as:

    Radiographic Healing: MRI with an absence of a fluid collection >2 cm in 3 of 3 dimensions, lack of edema, inflammation or sign of active inflammatory response. A remnant scar of a fistula tract may remain

    Clinical Healing: 100% cessation of drainage on both clinical exam with deep palpation and per patient report and complete closure of the fistula tract upon assessment with an examination under anesthesia


  2. Partial healing [ Time Frame: Month 6, Month 12 ]

    Number of participants with partial clinical healing post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of rectovaginal fistula in the setting of Crohn's disease

    Partial healing is defined as:

    Radiographic healing: MRI with an absence of a fluid collection >2 cm in 2 of 3 dimensions, lack of edema, inflammation or sign of active inflammatory response. A remnant scar of a fistula tract may remain

    Clinical healing: Greater than or equal to 50% cessation of drainage on both clinical exam with deep palpation and per patient report and partial closure of the fistula tract upon assessment with an examination under anesthesia


  3. Lack of response [ Time Frame: Month 6, Month 12 ]

    Number of participants with lack of response post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of rectovaginal fistula in the setting of Crohn's disease

    Lack of Response is defined as: Radiographic and clinical healing which does not meet the threshold for Partial Healing


  4. Worsening disease [ Time Frame: Month 6, Month 12 ]

    Number of participants with worsening disease post-injection of 75 million allogeneic bone marrow derived MSC's for the treatment of rectovaginal fistula in the setting of Crohn's disease

    Worsening disease is defined as:

    Radiographic: MRI with a fluid collection >2 cm in 2 of 3 dimensions, edema, inflammation or sign of active inflammatory response. An increased number of tracts may be seen, or increased branching from the primary tract,

    Clinical: Increased drainage per patient report and on clinical exam



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females 18-75 years of age with a diagnosis of Crohn's disease for at least six months duration.
  2. Single-tract, rectovaginal fistula in the setting of Crohn's disease.
  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, and ability to comply with protocol
  6. Concurrent Crohn's related therapies with stable doses (>2 months) corticosteroids, 5-ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin 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 subject.

  3. Specific exclusions:

    1. Hepatitis B or C
    2. HIV
    3. Abnormal AST or ALT at screening(defined as >/= 2x ULN)
  4. History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening.
  5. History of colorectal cancer within 5 years.
  6. Investigational drug within 30 days of treatment
  7. Pregnant or breast feeding or trying to become pregnant.
  8. Presence of a rectovaginal or perineal body fistula
  9. Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment
  10. Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment
  11. Severe anal canal disease that is stenotic and requires dilation
  12. Inability to wean corticosteroids
  13. Unwilling to agree to use acceptable contraception methods during participation in study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519697


Contacts
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Contact: Allison Bayles, AA 216-444-0887 ibdstemcelltherapy@ccf.org
Contact: Alex VanDenBossche, BSN 216-379-0307 ibdstemcelltherapy@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Allison Bayles         
Contact: Alex VanDenBossche         
Sponsors and Collaborators
Amy Lightner
Investigators
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Principal Investigator: Amy Lightner, MD The Cleveland Clinic
More Information
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Publications:

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Responsible Party: Amy Lightner, Sponsor-investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04519697    
Other Study ID Numbers: 20-936
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Lightner, The Cleveland Clinic:
Crohn's disease
rectovaginal fistula
mesenchymal stem cells
mesenchymal stem cell
Additional relevant MeSH terms:
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Crohn Disease
Rectovaginal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Rectal Fistula
 Intestinal Fistula
Digestive System Fistula
Rectal Diseases
Vaginal Fistula
Vaginal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases