Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519671
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2020-08-17
Brief Title:
Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohns Disease
Sponsor:
Amy Lightner
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Phase IBIIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohns Disease
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PFCD
Brief 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 Crohns disease
Detailed Description:
Crohns disease CD a chronic transmural inflammatory disease of the gastrointestinal tract continues to increase in incidence for unknown reasons According to population based studies at least 26 of patients with CD will develop perianal fistulas in the first two decades following diagnosis particularly those with colonic and rectal involvement These patients experience significant morbidity due to pain persistent drainage recurrent perianal sepsis and ongoing need to access medical care resulting in increased costs and impaired quality of life
Unfortunately perianal fistulizing Crohns disease is notoriously difficult to cure with 37 of patients experiencing refractory disease As a result patients cycle through numerous immunosuppressive medications that can have significant side effects and 90 undergo multiple surgical interventions putting them at risk of incontinence
The specific rationale for MSCs in perianal Crohns fistulas is based upon 1 their anti-inflammatory and immunomodulatory properties 2 several studies reporting the safety and efficacy of MSCs for the treatment of perianal Crohns fistula 3 existence of safe manufacturing methods for isolation and expansion of MSCs
This study will enroll 20 participants that have Crohns disease with medically and surgically refractory perianal fistulizing disease Participants enrolled will be those that meet particular criteria for participation in the clinical trial
Enrolled participants will be randomized to treatment group with adult allogeneic bone marrow derived mesenchymal stem cells versus placebo in a 31 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 participants 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 6 month visit to receive an injection of MSCs and again three months after this as above and will be followed for one year after treatment to a total duration of 18 months
Unfortunately perianal fistulizing Crohns disease is notoriously difficult to cure with 37 of patients experiencing refractory disease As a result patients cycle through numerous immunosuppressive medications that can have significant side effects and 90 undergo multiple surgical interventions putting them at risk of incontinence
The specific rationale for MSCs in perianal Crohns fistulas is based upon 1 their anti-inflammatory and immunomodulatory properties 2 several studies reporting the safety and efficacy of MSCs for the treatment of perianal Crohns fistula 3 existence of safe manufacturing methods for isolation and expansion of MSCs
This study will enroll 20 participants that have Crohns disease with medically and surgically refractory perianal fistulizing disease Participants enrolled will be those that meet particular criteria for participation in the clinical trial
Enrolled participants will be randomized to treatment group with adult allogeneic bone marrow derived mesenchymal stem cells versus placebo in a 31 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 participants 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 6 month visit to receive an injection of MSCs and again three months after this as above and will be followed for one year after treatment to a total duration of 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None