Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05215288
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-02-12
First Post:
2022-01-18
Brief Title:
Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
Sponsor:
Direct Biologics LLC
Organization:
Direct Biologics LLC
Study Overview
Official Title:
Intermediate Size Expanded Access for the Use of ExoFlo in the Treatment of Abdominal Solid Organ Transplant Patients Who Are at Risk of Worsening Allograft Function With Conventional Immunosuppressive Therapy Alone
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-07
Last Known Status:
None
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:
None
Brief Summary:
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ transplant at risk of worsening allograft function or at risk of complications from current immunosuppressive therapeutic regimens
Detailed Description:
Objectives
The primary objective of this expanded access program is to evaluate safety and tolerability of ExoFlo in patients with graft inflammation or worsening graft function or evidence of rejection of an abdominal solid organ transplant despite conventional therapies The secondary objective is to characterize the improvement seen in serum inflammatory markers and inflammation of solid abdominal organ
Endpoints
Primary Endpoint
Incidence of AEs or SAEs
Secondary Endpoint
Improvement seen in serum inflammatory markers and inflammation of solid abdominal organ This could include improvements seen in the following transplant types
Liver transplant overall improved liver function as seen by reduction in liver function test and improved albumin
Small bowel transplant decreased inflammation on biopsy
Pancreas decreased amylase and lipase
Multivisceral any of the above criteria
Number of subjects 20
Phase Expanded Access Protocol
The primary objective of this expanded access program is to evaluate safety and tolerability of ExoFlo in patients with graft inflammation or worsening graft function or evidence of rejection of an abdominal solid organ transplant despite conventional therapies The secondary objective is to characterize the improvement seen in serum inflammatory markers and inflammation of solid abdominal organ
Endpoints
Primary Endpoint
Incidence of AEs or SAEs
Secondary Endpoint
Improvement seen in serum inflammatory markers and inflammation of solid abdominal organ This could include improvements seen in the following transplant types
Liver transplant overall improved liver function as seen by reduction in liver function test and improved albumin
Small bowel transplant decreased inflammation on biopsy
Pancreas decreased amylase and lipase
Multivisceral any of the above criteria
Number of subjects 20
Phase Expanded Access Protocol
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