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

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.