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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells
DrugAllogeneic 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
Drug0.9% 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).
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Allogeneic adipose-derived HB-adMSCsExperimental treatment 1 intervention
Group B: 0.9% sodium chloridePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes from Baseline in Crohns Disease Activity Index (CDAI) Scores.
Changes from Baseline (Week 0) up to Week 52 in Crohn's Disease Activity Index (CDAI) scores. Specifically, clinical response defined as a reduction of at least 100 points in Crohn's Disease Activity Index (CDAI) from baseline. Score ranges from 0 (minimum) - 450 (maximum), the least being asymptomatic and the greatest being most severe.
Time frame
Week 0 (Visit 1) to Week 52 (Visit 9)Secondary outcomes
1
Incidence of serious adverse events (SAEs).
Incidence of serious adverse events (SAEs).
Time frame
Week 0 (Visit 1) to Week 52 (Visit 9)2
Incidence of treatment-emergent adverse events (TEAEs).
Incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events are defined as any adverse events which occur after the first treatment (Week 0) up to the Follow Up Visit (Week 20).
Time frame
Week 0 (Visit 1) to Week 20 (Visit 8)3
Incidence and risk of AEs of particular interest (serious or non serious), including thromboembolic events, infections, and hypersensitivities
Incidence and risk of AEs of particular interest (serious or non serious), including thromboembolic events, infections, and hypersensitivities.
Time frame
Week 0 (Visit 1) to Week 52 (Visit 9)4
Changes from Baseline in laboratory values results - Complete Blood Count (x10^3 Cells/uL)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (x10\^3 Cells/uL)
Time frame
Week 0 (Visit 1) to Week 52 (Visit 9)Other outcomes
1
Change from Baseline in C-Reactive Protein values.
Clinically significant changes in C-Reactive Protein values.
Time frame
Week 0 (Visit 1) to Week 52 (Visit 9)2
Change from Baseline in erythrocyte sedimentation rate values.
Clinically significant changes in erythrocyte sedimentation rate values.
Time frame
Week 0 (Visit 1) to Week 52 (Visit 9)Sponsors and contacts
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Source ClinicalTrials.gov