Pediatric MSC-AFP Sub-study for Crohn's Fistula
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03449069|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fistula in Ano Crohn Disease||Drug: MSC-AFP||Phase 1|
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells. 5 patients (age 12 to 17 years) with Crohn's perianal fistulas will be enrolled.
Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2021|
This is a single treatment group study. All patients will receive treatment of a stem cell coated fistula plug.
Patients will have a mesenchymal stromal cell coated anal fistula plug placed in their Crohn's perianal fistula tract.
Other Name: mesenchymal stromal cell coated anal fistula plug
- Number of participants with treatment-related adverse events (safety and toxicity) [ Time Frame: 2 months to approximately at 24 months ]Participants will have a health assessment and blood work done at each study visit to monitor for adverse events.
- Number of participants with response to the treatment regarding cessation of drainage from the treated fistula. [ Time Frame: 2 months to approximately at 24 months ]Participants will have a clinical assessment of fistula drainage at each study visit.
- Number of participants with radiographic response to the treatment regarding the treated fistula. [ Time Frame: Week 2, Week 8, and Week 24 ]Participants will have an assessment of healing radiographically by magnetic resonance imaging (MRI) at Week 2 visit, Week 8, and Week 24.
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): NCT03449069
|Contact: Jessica Fritonfirstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Jessica Friton 507-284-0495 email@example.com|
|Principal Investigator: Michael C Stephens|
|Principal Investigator:||Michael C Stephens||Mayo Clinic|