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

NCT05215288 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-07-29

No results posted yet for this study

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

Interventions

BIOLOGICAL

ExoFlo

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Sponsors & Collaborators

  • Direct Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Bill Arana · Direct Biologics, LLC

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05215288 on ClinicalTrials.gov