Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
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|ClinicalTrials.gov Identifier: NCT05215288|
Expanded Access Status : Available
First Posted : January 31, 2022
Last Update Posted : April 19, 2023
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|Condition or disease||Intervention/treatment|
|Solid Organ Transplant Rejection Organ Rejection Transplants Organ Rejection||Biological: ExoFlo|
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.
Incidence of AEs or SAEs.
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
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|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|
- Biological: ExoFlo
Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Pregnant or breastfeeding.
- Treatment with another investigational drug or other intervention within 30 days of enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05215288
|Contact: Amy Lightner, MDemail@example.com|
|Contact: Stephanie Cahillfirstname.lastname@example.org|
|Study Director:||Amy Lightner, MD||Direct Biologics, LLC|
|Responsible Party:||Direct Biologics, LLC|
|Other Study ID Numbers:||
|First Posted:||January 31, 2022 Key Record Dates|
|Last Update Posted:||April 19, 2023|
|Last Verified:||April 2023|
Organ Rejection Transplants
Solid Organ Transplant Rejection