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

Not Recruiting

Trial ID: NCT05215288

Purpose

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.

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

Stanford Investigator(s)

Ke-You (Yoyo) Zhang

Clinical Assistant Professor, Pediatrics - Gastroenterology

Eligibility


Inclusion Criteria:

   1. Provision of signed and dated informed consent form.

   2. Stated willingness to comply with all study procedures and availability for the
   duration of the study.

   3. Male or female, ages 18 to 75.

   4. Previous abdominal solid organ transplant, including intestinal transplant.

   5. Diagnosis of acute or chronic rejection / inflammation based on clinical observations,
   laboratory analysis, histological evaluation.

   6. Diagnosis of worsening allograft function based on clinical observations, laboratory
   analysis, histological evaluation.

   7. Failed primary and alternate standard of care therapies.

   8. Serious or life-threatening condition or progressing to serious or life-threatening
   condition if not treated as evaluated by the treating physician.

   9. In otherwise good general health as evidenced by medical history.

10. 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 Criteria:

   1. Pregnant or breastfeeding.

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

Intervention(s):

biological: ExoFlo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305