NO_LONGER_AVAILABLENot Applicable

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

United States

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

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

Trial details

NCT IDNCT05215288

SponsorDirect Biologics, LLC

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Solid Organ Transplant Rejection trials