RECRUITING

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.

Official Title

A Phase 2a Study of Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product (DB-3Q) in Patients With Perianal Fistulizing Crohn's Disease

Quick Facts

Study Start:2025-05-19

Study Completion:2026-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06918808

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written informed consent from participant 2. Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1 3. Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining 4. Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib) 5. Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula 6. Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)	1. Lack of informed consent 2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding 3. A participant who is unwilling to use medically acceptable contraception methods during participation in study 4. Active perianal abscess or infection at screening or Day 1 5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant 6. Confirmed HIV, Hepatitis B, or Hepatitis C infections 7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening 8. History of colorectal cancer within 2 years of screening 9. Use of investigational therapy or treatment within 30 days prior to Day 1

Inclusion Criteria

Exclusion Criteria

1. Written informed consent from participant
2. Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1
3. Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining
4. Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)
5. Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula
6. Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)

1. Lack of informed consent
2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
3. A participant who is unwilling to use medically acceptable contraception methods during participation in study
4. Active perianal abscess or infection at screening or Day 1
5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant
6. Confirmed HIV, Hepatitis B, or Hepatitis C infections
7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening
8. History of colorectal cancer within 2 years of screening
9. Use of investigational therapy or treatment within 30 days prior to Day 1

Contacts and Locations

Study Contact

Executive Vice President, Clinical Affairs, MS

CONTACT

1-800-791-1021

clinicalaffairs@directbiologics.com

Study Locations (Sites)

Columbia University Irving Medical Center/NYPH

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Direct Biologics, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-19

Study Completion Date2026-10-31

Study Record Updates

Study Start Date2025-05-19

Study Completion Date2026-10-31

Terms related to this study

Additional Relevant MeSH Terms

Perianal Fistula Due to Crohn's Disease