HB-adMSCs for the Treatment of Crohn's Disease
ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHope Biosciences Research Foundation
About this trial
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
Eligibility criteria
Qualifiers
Male and female subjects who are ≥ 18 years old and ≤ 65 years old.
Clinical presentation of symptoms such as diarrhea, abdominal pain, weight loss, fever, and fatigue
Radiologic Findings within 3 years of screening date: Imaging studies like CT scans or MRI scans of the abdomen and pelvis that indicate bowel wall thickening, strictures, fistulas, and abscesses characteristic of Crohn's disease
Histologic Findings within 3 years of screening date: Microscopic examination of tissue biopsies that indicate transmural inflammation with lymphoid infiltrates
Disqualifiers
WBC: <3000 cells/μL OR >15000 cells/μL (<3 K cells/μL or >15 K cells/μL)
Absolute Neutrophil Count: <1500 cells/μL
Sodium: <120 mEq/L OR >150 mEq/L
Glucose: >150 mg/dL (for fasting subjects)
Trial design
Treatments tested in this trial
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells
- 0.9% sodium chloride
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov