HB-adMSCs treatment for Crohn's disease

A Randomized, Double-Blind, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Crohn's Disease

This trial will try intravenous HB-adMSCs versus placebo to see if they improve symptoms in adults 18–65 with Crohn's disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hope Biosciences Research Foundation (Industry-sponsored)
• Locations: 1 site (Sugar Land, Texas)
• Trial ID: NCT07077746 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind Phase 2 trial comparing multiple intravenous infusions of allogeneic HB-adMSCs to placebo in 46 adults with Crohn's disease. Participants receive treatments over a 16-week period with safety and efficacy follow-up through 52 weeks after the first infusion. The primary outcome is change in Crohn's Disease Activity Index (CDAI) with a clinically important difference defined as a ≥100-point decrease; secondary outcomes include safety and changes in fecal calprotectin. Exploratory measures include changes in CRP and ESR to characterize inflammatory response.

Who should consider this trial

Good fit: Adults aged 18–65 with a confirmed Crohn's disease diagnosis for at least 6 months and active disease who can travel to the study site are the intended participants.

Not a fit: People outside the 18–65 age range, those without confirmed Crohn's disease, or those with medical conditions excluded by screening are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the treatment could reduce Crohn's symptoms and inflammatory markers, potentially helping patients achieve clinical improvement or remission.

How similar studies have performed: Previous small studies of mesenchymal stem cell therapies—especially for perianal fistulas—have shown promise, but systemic IV allogeneic adipose-derived MSCs for luminal Crohn's remain experimental.

Eligibility criteria

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 characteristic of Crohn's disease
   3. Histologic Findings within 3 years of screening date: Microscopic examination of tissue biopsies that indicate transmural inflammation with lymphoid infiltrates
   4. Exclusion of other conditions: Differential diagnoses, such as ulcerative colitis, infectious enterocolitis, and drug-induced colitis, must be excluded through appropriate evaluation
3. Must have CDAI scores at the screening visit of ≥ 150 to ≤ 450, indicating Mild or Moderate Crohn's Disease.
4. 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.
5. 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).
6. 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.
7. 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.)
8. 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:

   1. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
   2. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
   3. Barrier contraceptive methods (condoms, diaphragm, etc.). OR Male subjects if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and for 6 months after the last administration of the investigated product:.

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   1. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
   2. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
   3. Barrier contraceptive methods (condoms, diaphragm, etc.).
9. Study subjects are able and willing to comply with the requirements of this clinical trial.
10. Voluntarily signed informed consent from study subject or legally authorized representative obtained before any clinical-trial related procedures are performed.

Exclusion Criteria:

1. Study subject has any of the following laboratory results at the screening visit:

   1. WBC: \&lt;3000 cells/μL OR \&gt;15000 cells/μL (\&lt;3 K cells/μL or \&gt;15 K cells/μL)
   2. Absolute Neutrophil Count: \&lt;1500 cells/μL
   3. Sodium: \&lt;120 mEq/L OR \&gt;150 mEq/L
   4. Glucose: \&gt;150 mg/dL (for fasting subjects)
   5. Potassium: \&lt;3.5 mEq/L OR \&gt;6 mEq/L
   6. BUN: \&gt;25 mg/dL
   7. Creatinine: \&gt;2 mg/dL
   8. BUN/Creatinine ratio: \&gt;50
2. Study subject has CDAI scores of \&lt; 150 or \&gt; 450 at the screening visit.
3. Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.
4. Study subject has any of the following cardiovascular issues:

   1. Severe heart failure (e.g., NYHA Class III/IV)
   2. Uncontrolled arrhythmias
   3. Recent myocardial infarction (\&lt;6 months from screening visit)
   4. Uncontrolled hypertension
5. Study Subject has any of the following pulmonary diseases:

   1. Severe COPD
   2. Pulmonary fibrosis
   3. History of recent (\&lt;6 months from screening visit) pulmonary embolism or DVT
6. Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:

   1. Diabetes Mellitus
   2. Rheumatoid Arthritis
   3. Lupus
   4. Multiple Sclerosis
7. Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
8. Study subject has a history of cancer within 5 years of screening visit (unless curatively treated and without recurrence)
9. Study subject has known alcoholic addiction or dependency or has current substance use or abuse.
10. Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.
11. Study subject has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.
12. Study subject unable to understand and provide signed informed consent.
13. Study subject unlikely to complete the study or adhere to the study procedures.
14. Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
15. Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
16. Female subjects who plan to donate eggs or undergo in vitro fertilization treatment during the study within 6 months after the last infusion. OR Male subjects who plan to donate sperm during the study within 6 months after the last infusion.

Where this trial is running

Sugar Land, Texas

• Hope Biosciences Research Foundation — Sugar Land, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Thanh Cheng, MD — Hope Biosciences Research Foundation
• Study coordinator: David Gonzalez, RN

Conditions Crohn Disease; Crohn' s; s Disease; Autoimmune; CD; IBD; Inflammatory bowel disease