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

NCT06918808 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 3Q-PFCD-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Perianal Fistula Due to Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Combined Remission

  Clinically confirmed 100% closure of all treated external openings, without development of new fistulas or abscesses and drainage \> 1 cm by the external openings, occurring spontaneously or after gentle finger compression; and on blinded central review of the MRI results, combined imaging endpoint of \>50% reduction in MAGNIFI-CD score and \>20% increase in perianal fistula fibrosis-to-fluid ratio.

  24 Weeks

Secondary Outcomes (1)

• Combined Remission

  12 Weeks

Study Arms (6)

Single dose DB-3Q 15 mL direct injection

EXPERIMENTAL

Biological: DB-3Q

Single dose Placebo 15 mL direct injection

PLACEBO COMPARATOR

Biological: Placebo

Single dose DB-3Q 30 mL direct injection

EXPERIMENTAL

Biological: DB-3Q

Single dose Placebo 30 mL direct injection

PLACEBO COMPARATOR

Biological: Placebo

Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection

EXPERIMENTAL

Biological: DB-3Q

Single dose Placebo 15 ml IV and Placebo 30 mL direct injection

PLACEBO COMPARATOR

Biological: Placebo

Interventions

DB-3Q BIOLOGICAL

DB-3Q (IMP) is the frozen liquid formulation of acellular secretome proteins and extracellular vesicles isolated from human bmMSC and processed under current Good Manufacturing Process standards.

Single dose DB-3Q 15 mL direct injection; Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection; Single dose DB-3Q 30 mL direct injection

Placebo BIOLOGICAL

0.9% NaCl

Single dose Placebo 15 mL direct injection; Single dose Placebo 15 ml IV and Placebo 30 mL direct injection; Single dose Placebo 30 mL direct injection

Eligibility Criteria

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

You may qualify if:

• Written informed consent from participant
• 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
• Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining
• 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)
• 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
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Direct Biologics, LLC: lead

Study Sites (3)

Direct Biologics Investigational Site

Aurora, Colorado, 80045, United States

RECRUITING

Direct Biologics Investigational Site

St Louis, Missouri, 63130, United States

RECRUITING

Columbia University Irving Medical Center/NYPH

New York, New York, 10032, United States

RECRUITING

Central Study Contacts

Executive Vice President, Clinical Affairs, MS

CONTACT

1-800-791-1021; clinicalaffairs@directbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 PFCD.

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: May 19, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)