HB-adMSCs for the Treatment of Crohn's Disease

NCT07077746 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HBCD01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Crohn Disease (CD)

Keywords

Crohn's; Crohn's Disease; Autoimmune; CD; IBD; Inflammatory bowel disease; biologic; stem cell

Outcome Measures

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.

  Week 0 (Visit 1) to Week 52 (Visit 9)

Secondary Outcomes (36)

• Incidence of serious adverse events (SAEs).

  Week 0 (Visit 1) to Week 52 (Visit 9)

• Incidence of treatment-emergent adverse events (TEAEs).

  Week 0 (Visit 1) to Week 20 (Visit 8)

• Incidence and risk of AEs of particular interest (serious or non serious), including thromboembolic events, infections, and hypersensitivities

  Week 0 (Visit 1) to Week 52 (Visit 9)

• Changes from Baseline in laboratory values results - Complete Blood Count (x10^3 Cells/uL)

  Week 0 (Visit 1) to Week 52 (Visit 9)

• Changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)

  Week 0 (Visit 1) to Week 52 (Visit 9)

Other Outcomes (2)

• Change from Baseline in C-Reactive Protein values.

  Week 0 (Visit 1) to Week 52 (Visit 9)

• Change from Baseline in erythrocyte sedimentation rate values.

  Week 0 (Visit 1) to Week 52 (Visit 9)

Study Arms (2)

Allogeneic adipose-derived HB-adMSCs

EXPERIMENTAL

Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells), Intravenous

Drug: HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells

0.9% sodium chloride

PLACEBO COMPARATOR

0.9% sodium chloride, Intravenous

Drug: 0.9% sodium chloride

Interventions

HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells DRUG

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).

Allogeneic adipose-derived HB-adMSCs

0.9% sodium chloride DRUG

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).

0.9% sodium chloride

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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).
• 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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You may not qualify if:

• Study subject has any of the following laboratory results at the screening visit:
• WBC: \&lt;3000 cells/μL OR \&gt;15000 cells/μL (\&lt;3 K cells/μL or \&gt;15 K cells/μL)
• Absolute Neutrophil Count: \&lt;1500 cells/μL
• Sodium: \&lt;120 mEq/L OR \&gt;150 mEq/L
• Glucose: \&gt;150 mg/dL (for fasting subjects)
• Potassium: \&lt;3.5 mEq/L OR \&gt;6 mEq/L
• BUN: \&gt;25 mg/dL
• Creatinine: \&gt;2 mg/dL
• BUN/Creatinine ratio: \&gt;50
• Study subject has CDAI scores of \&lt; 150 or \&gt; 450 at the screening visit.
• Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.
• Study subject has any of the following cardiovascular issues:
• Severe heart failure (e.g., NYHA Class III/IV)
• Uncontrolled arrhythmias
• Recent myocardial infarction (\&lt;6 months from screening visit)

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Research Foundation

Sugar Land, Texas, 77478, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thanh Cheng, MD

  Hope Biosciences Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Gonzalez, RN

CONTACT

346-900-0340; david@hopebio.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This clinical trial is a double-blinded study, meaning that the subjects and the researchers both do not know the group assignments. Research staff and subjects may be unblinded once all study data has been collected, all study-related procedures and follow-ups are completed, and all monitoring has been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a randomized, double-blind, phase 2, efficacy and safety study of allogeneic HB-adMSCs vs placebo for the treatment of Crohn's Disease. This clinical trial includes a screening period (up to 35 days), a 16-week treatment period and a safety and efficacy follow up period for 52 weeks post first treatment.

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 22, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)