HB-adMSCs for the Treatment of Crohn's Disease (NCT07077746) | Clinical Trial Compass
RecruitingPhase 2
HB-adMSCs for the Treatment of Crohn's Disease
United States46 participantsStarted 2026-05
Plain-language summary
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
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female subjects who are ≥ 18 years old and ≤ 65 years old.
✓. 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:
✓. 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
Exclusion criteria
✕. Must have CDAI scores at the screening visit of ≥ 150 to ≤ 450, indicating Mild or Moderate Crohn's Disease.
✕. Subjects without a current established treatment for Crohn's Disease, or if being treated, subjects who are on a stable dose of Crohn's Disease therapy regimen for ≥3 months prior to screening.
✕. Subjects must be willing to maintain their established treatment for Crohn's Disease (or lack thereof) for the duration of the study. Subjects must acknowledge that they may be removed from participation in the study for failure to maintain their established treatment for Crohn's Disease (or lack thereof).
✕. Subjects must have an elevated CRP value at the screening visit of ≥1 mg/L and/or an abnormal ESR value at the screening visit of \> 15 mm/hr. for male subjects or \> 20 mm/hr. for female subjects.
What they're measuring
1
Changes from Baseline in Crohns Disease Activity Index (CDAI) Scores.
✕. Subjects must be able to provide the latest (specifically, within 3 years of screening date) diagnostic imaging records for their Crohn's Disease (including but not limited to endoscopy, colonoscopy, MRI scans, ultrasounds, etc.)
✕. Female study subjects of childbearing potential should not be pregnant or plan to become pregnant during study participation and for 6 months after the last investigational product administration. Female study subjects of childbearing potential must confirm usage of one of the following contraceptive measures:
✕. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
✕. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).