HB-adMSCs for the Treatment of Crohn's Disease

Part of paid clinical trials in Sugar Land, Texas.

Sponsor
Hope Biosciences Research Foundation
Study ID
NCT07077746
Phase
PHASE2
Status
Recruiting
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Conditions

  • Crohn Disease (CD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells — DRUG
    Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells). Dose: 200 million cells (+/- 20%) suspended in 20mL 0.9% sodium chloride. Route: Intravenous. Regimen: Weeks 0, 2, 4, 8, 12, and 16. Preparation: HB-adMSCs syringe should be diluted in 250 mL 0.9% sodium chloride (for a total volume of 270 mL).
  • 0.9% sodium chloride — DRUG
    0.9% sodium chloride Dose: N/A - 20mL 0.9% sodium chloride. Route: Intravenous. Regimen: Weeks 0, 2, 4, 8, 12, and 16. Preparation: Placebo syringe should be diluted in 250 mL 0.9% sodium chloride (for a total volume of 270 mL).

Study Details

Methodology: Randomized, double-blind, efficacy and safety study of allogeneic HB-adMSCs vs placebo for the treatment of Crohn's Disease with a 16-week treatment period and a safety and efficacy follow up period for 52 weeks post first treatment. Treatment Duration: 16 weeks General Objectives: To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of Crohn's Disease in this subject population. Number of Subjects: 46 (23 in each treatment arm) Indication: Crohn's Disease

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Allogeneic adipose-derived HB-adMSCs
    Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells), Intravenous
  • Placebo Comparator: 0.9% sodium chloride
    0.9% sodium chloride, Intravenous

Primary Outcome Measure

Changes from Baseline in Crohns Disease Activity Index (CDAI) Scores. [ Time Frame: Week 0 (Visit 1) to Week 52 (Visit 9) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hope Biosciences Research FoundationSugar LandTexas77478
David Gonzalez, RN
[email protected]
346-900-0340
Thanh Cheng, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Hope Biosciences Research Foundation· Sugar Land, TX

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