Clinical trial NCT05215288: Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Solid Organ Transplant Rejection
Organ Rejection Transplants
Organ Rejection
Keywords: ExoFlo
Organ Rejection
Organ Rejection Transplants
Solid Organ Transplant Rejection
Lead sponsor: Direct Biologics, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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 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.

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 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

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Direct Biologics Investigational Site
state: California
city: San Francisco
country: United States
facility: Direct Biologics Investigational Site
state: California
Study officials:
affiliation: Direct Biologics, LLC
name: Bill Arana
role: STUDY_DIRECTOR
References: