Finding studies
Finding studies
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Lead
Direct Biologics, LLC
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
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
