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

Conditions

• Perianal Fistula Due to Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

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.
• Placebo — BIOLOGICAL
  0.9% NaCl

Study 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 Perianal Fistulizing Crohn's Disease.

Key Dates

Start date

May 19, 2025

Status verified

Feb 2026

Primary completion

Jul 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Single dose DB-3Q 15 mL direct injection
• Placebo Comparator: Single dose Placebo 15 mL direct injection
• Experimental: Single dose DB-3Q 30 mL direct injection
• Placebo Comparator: Single dose Placebo 30 mL direct injection
• Experimental: Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection
• Placebo Comparator: Single dose Placebo 15 ml IV and Placebo 30 mL direct injection

Primary Outcome Measure

Combined Remission [ Time Frame: 24 Weeks ]

Central Contacts

• Executive Vice President, Clinical Affairs, MS
  1-800-791-1021
  [email protected]

Locations (5)

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