Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05215288
Expanded Access Status : Available
First Posted : January 31, 2022
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Direct Biologics, LLC

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.

Condition or disease Intervention/treatment
Solid Organ Transplant Rejection Organ Rejection Transplants Organ Rejection Biological: ExoFlo

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

Layout table for study information
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: ExoFlo
    Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Amy Lightner, MD 512-354-7124 alightner@directbiologics.com
Contact: Stephanie Cahill scahill@directbiologics.com

Sponsors and Collaborators
Direct Biologics, LLC
Investigators
Layout table for investigator information
Study Director: Amy Lightner, MD Direct Biologics, LLC
Additional Information:
Layout table for additonal information
Responsible Party: Direct Biologics, LLC
ClinicalTrials.gov Identifier: NCT05215288    
Other Study ID Numbers: DB-EF-TP_ASO-1a
First Posted: January 31, 2022    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Keywords provided by Direct Biologics, LLC:
ExoFlo
Organ Rejection
Organ Rejection Transplants
Solid Organ Transplant Rejection