By efain on
Email
expandedaccess@directbiologics.com
ClinicalTrials.gov URL
https://clinicaltrials.gov/ct2/results?cond=&term=exoflo&cntry=&state=&city=&dist=
Acknowledgement
5 business days
EA Page
https://directbiologics.com/compassionate-use-policy/
Sponsor
Direct Biologics, LLC
EA Therapies for Single Patient

ExoFlo (extracellular vesicles isolated from human bone marrow mesenchymal stromal/stem cells)

EA Policies for Single Patient
  • There must be adequate supply of the investigational product to meet the needs of the expanded access program without impacting the company’s clinical trials
  • There is a compelling medical and scientific rationale for the requested use
  • The potential benefit to the patient must outweigh the collective potential risks
  • There must be sufficient clinical data to identify an appropriate dose
  • The patient’s physician has determined that treating the patient with the investigational product is in the patient’s best interests