NCT05215288

Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients

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
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Direct Biologics, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Organ Transplant Rejection
• Organ Rejection Transplants
• Organ Rejection

Interventions

Type	Name	Description
BIOLOGICAL	ExoFlo	Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Timeline

• First posted: 2022-01-31
• Last updated: 2024-07-29

Locations

2 sites across 1 country: United States