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

NCT05215288 | Unknown

• 1 other identifier: DB-EF-TP_ASO-1a
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Organ Transplant Rejection; Organ Rejection Transplants; Organ Rejection

Keywords

ExoFlo; Organ Rejection; Organ Rejection Transplants; Solid Organ Transplant Rejection

Interventions

ExoFlo BIOLOGICAL

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding.
• Treatment with another investigational drug or other intervention within 30 days of enrollment.

Sponsors & Collaborators

• Direct Biologics, LLC: lead

Study Sites (2)

Direct Biologics Investigational Site

Palo Alto, California, 94304, United States

Location

Direct Biologics Investigational Site

San Francisco, California, 94143, United States

Location

Related Links

• Direct Biologics, LLC

Study Officials

• Bill Arana

  Direct Biologics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

US (2)