Actively Recruiting
HB-adMSCs for the Treatment of Crohn's Disease
Led by Hope Biosciences Research Foundation · Updated on 2026-04-22
46
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
HB-adMSCs for the Treatment of Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to 65 years
- Diagnosed with Crohn's Disease at least 6 months before screening, confirmed by symptoms, imaging, or tissue biopsy
- CDAI score between 150 and 450 indicating mild or moderate disease
- Either not currently treated or on a stable Crohn's Disease treatment regimen for at least 3 months
- Willing to maintain current treatment status throughout the study
- Elevated CRP (>=1 mg/L) and/or abnormal ESR at screening (>15 mm/hr for males, >20 mm/hr for females)
- Able to provide recent diagnostic imaging records within 3 years
- Female participants of childbearing potential not pregnant and using approved contraception during and 6 months after the study; males with partners of childbearing potential to use contraception
- Able and willing to comply with study requirements
- Provided informed consent
You will not qualify if you...
- White blood cell count less than 3000 or greater than 15000 cells/µL
- Absolute neutrophil count less than 1500 cells/µL
- Sodium levels below 120 or above 150 mEq/L
- Fasting glucose above 150 mg/dL
- Potassium levels below 3.5 or above 6 mEq/L
- Blood urea nitrogen (BUN) above 25 mg/dL
- Creatinine above 2 mg/dL
- BUN/Creatinine ratio above 50
- CDAI score below 150 or above 450
- Vital sign abnormalities deemed significant by investigator
- Severe cardiovascular conditions such as severe heart failure, uncontrolled arrhythmias, recent heart attack within 6 months, or uncontrolled hypertension
- Severe pulmonary diseases including severe COPD, pulmonary fibrosis, or recent pulmonary embolism or deep vein thrombosis within 6 months
- Significant uncontrolled medical conditions like diabetes, rheumatoid arthritis, lupus, or multiple sclerosis
- Any active malignancy or cancer history within 5 years unless cured without recurrence
- Known alcohol addiction or current substance abuse
- Receipt of investigational or approved therapy for investigational use within 1 year prior to first dose (excluding COVID-19 vaccines)
- Other laboratory abnormalities or medical conditions posing safety risks or preventing study completion
- Unable to provide informed consent or unlikely to complete the study
- Known acute or chronic infections including hepatitis B, hepatitis C, or HIV
- Systemic infection requiring treatment within 30 days prior to first dose
- Female planning egg donation or IVF, or male planning sperm donation during the study and 6 months after last infusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hope Biosciences Research Foundation
Sugar Land, Texas, United States, 77478
Actively Recruiting
Research Team
D
David Gonzalez, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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