Crohn Disease Clinical Trial
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.
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04046913 -
The ADDapt Diet in Reducing Crohn's Disease Inflammation
|
N/A | |
| Recruiting |
NCT05169593 -
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
|
Phase 4 | |
| Recruiting |
NCT06116604 -
Early Bowel Resection for Terminal Ileal Crohn's Disease
|
||
| Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
| Recruiting |
NCT05294107 -
Intestinal Organoids
|
N/A | |
| Recruiting |
NCT05627128 -
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
|
N/A | |
| Withdrawn |
NCT04349449 -
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
|
||
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Completed |
NCT03058679 -
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
|
N/A | |
| Completed |
NCT02871635 -
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
|
Phase 3 | |
| Recruiting |
NCT04539665 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
|
N/A | |
| Recruiting |
NCT04266600 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
|
N/A | |
| Recruiting |
NCT03913572 -
Treatment of Perianal Disease Using Adipose-derived Stem Cells
|
||
| Completed |
NCT03606499 -
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
|
||
| Completed |
NCT03668249 -
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
|
||
| Terminated |
NCT04102111 -
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
|
Phase 2 | |
| Recruiting |
NCT04997733 -
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
|
Phase 3 | |
| Recruiting |
NCT05906576 -
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
|
Phase 4 | |
| Not yet recruiting |
NCT04502303 -
18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease
|
Phase 2 | |
| Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 |