Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636032
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Dose Escalation of Allogeneic Adipose Derived StromaStem Cells for the Treatment of Crohns Fistula
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dose Escalation of Allogeneic Adipose Derived StromaStem Cells for the Treatment of Crohns Fistulaa Phase III Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLOFIST
Brief Summary:
Perianal fistulas are in the forefront 42 to 72 4 of morbid complication of Crohns disease affecting nearly one- third of patients and complicating abscesses in 35-48 of cases The current treatment is based on the combination of drainage proctologic and surgical and biologics techniques but the failure rate varies from 30 to 80 Actually innovative cell therapy procedures are validated by Cell-Easy with the use of allogenic mesenchymal stem cells for the immunomodulatory anti-inflammatory angiogenic and trophic properties CellReady and represent a promising option in the treatment of perianal fistulas associated with Crohns disease This phase III study is designed to evaluate the treatment of complex perianal fistulas associated with Crohns disease after failure of conventional treatment by injection of allogeneic cultured adipose-derived stromal cell AdMSC into the fistula
Detailed Description:
The injection of adipose stromal cells is currently evaluated in clinical studies for repair-damaged tissues in various diseases limb ischemia osteoarthritis systemic slerosis Immunoregulatory and anti-inflammatory properties of AdMSCs are responsible for accelerating healing and represents an innovative approach to treat perianal fistulas associated with Crohns disease
This phase III study is designed to evaluate the treatment of complex perianal fistulas associated with Crohns disease after failure of conventional treatment by injection of AdMSC CellReady into the fistula
Different doses of AdMSC will be tested for a dose escalation 5107 and 10107 cells and injected in the in the wall of the fistula
This phase III study is designed to evaluate the treatment of complex perianal fistulas associated with Crohns disease after failure of conventional treatment by injection of AdMSC CellReady into the fistula
Different doses of AdMSC will be tested for a dose escalation 5107 and 10107 cells and injected in the in the wall of the fistula
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None