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

Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

Direct Biologics, LLC

Conditions:

Solid Organ Transplant Rejection

Organ Rejection Transplants

Eligibility:

All Genders

18-75 years

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 b...

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 rej...

Eligibility Criteria

Inclusion

Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, ages 18 to 75.
Previous abdominal solid organ transplant, including intestinal transplant.
Diagnosis of acute or chronic rejection / inflammation based on clinical observations, laboratory analysis, histological evaluation.
Diagnosis of worsening allograft function based on clinical observations, laboratory analysis, histological evaluation.
Failed primary and alternate standard of care therapies.
Serious or life-threatening condition or progressing to serious or life-threatening condition if not treated as evaluated by the treating physician.
In otherwise good general health as evidenced by medical history.
Male or female of reproductive potential must utilize a medically effective birth control method during from time of enrollment to 6 months after last dose of IMP.

Exclusion

Pregnant or breastfeeding.
Treatment with another investigational drug or other intervention within 30 days of enrollment.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT05215288

Last Update

July 29 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

Direct Biologics Investigational Site

Palo Alto, California, United States, 94304