Hope Biosciences Research Foundation
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
Primary Objective: \- To investigate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in Crohn's Disease Activity Index (CDAI) scores. (Time Frame: Week 0 to Week 52). Minimal clinically important difference (MCID) for CDAI is defined as a decrease of ≥100 points. Secondary Objectives: * To assess the safety of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by the incidence of adverse events or serious adverse events. (Time Frame: Week 0 to Week 52)…
Inclusion Criteria: 1. Male and female subjects who are ≥ 18 years old and ≤ 65 years old. 2. Must be diagnosed with Crohn's Disease at least 6 months prior to the screening visit, as verified by one or more of the following diagnostic criteria present in the participant's medical records: 1. Clinical presentation of symptoms such as diarrhea, abdominal pain, weight loss, fever, and fatigue 2. 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…
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 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).
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