Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
AgeNot listed
SponsorAvobis Bio, LLC
About this trial
The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial (STOMP-II), but who were subsequently not treated with AVB-114 because they did not meet all eligibility criteria or the investigational product was not successfully manufactured.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated ICF.
Adipose tissue previously collected per the STOMP-II protocol, but were subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew.
Diagnosed with Crohn's disease and a target perianal fistula with one internal opening and at least one external opening.
Disqualifiers
Suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety.
Pregnant, trying to become pregnant, or are breast feeding. Women of childbearing potential (WCBP) and males who have sexual partners that are WCBP must agree to use an adequate method of contraception while participating in this EAP.
Known allergies or hypersensitivity to aminoglycosides.
History of clinically significant fat-directed autoimmunity.
Trial design
Treatments tested in this trial
AVB-114
Biological/VaccineAVB-114 is a mesenchymal cell substrate system comprised of autologous mesenchymal cells incubated with a 3-dimensional bioabsorbable substrate. The drug substance is expanded, pure mesenchymal stem cells (MSC) which are known to modulate local inflammation and orchestrate tissue healing. By incubating cells with a 3-dimensional bioabsorbable substrate designed for anal fistula geometry, cells are locally delivered into the fistula tract to promote healing.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Avobis Bio, LLC
Lead sponsor
Alimentiv Inc.
Collaborator
Source ClinicalTrials.gov