Crohn Disease (CD)Phase 2NCT07077746
HB-adMSCs for the Treatment of Crohn's Disease
A Phase 2 study testing HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells and 0.9% sodium chloride in people with Crohn Disease (CD), run by Hope Biosciences Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells and 0.9% sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 of other conditions: Differential diagnoses, such as ulcerative colitis, infectious enterocolitis, and drug-induced colitis, must be excluded through appropriate evaluation
Show all 21Show fewer
- 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:.
- <!-- -->
- 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.).
- Study subjects are able and willing to comply with the requirements of this clinical trial.
- Voluntarily signed informed consent from study subject or legally authorized representative obtained before any clinical-trial related procedures are performed.
Who cannot join
- Study subject has any of the following laboratory results at the screening visit:
- 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)
- Potassium: \<3.5 mEq/L OR \>6 mEq/L
Show all 35Show fewer
- BUN: \>25 mg/dL
- Creatinine: \>2 mg/dL
- BUN/Creatinine ratio: \>50
- Study subject has CDAI scores of \< 150 or \> 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 (\<6 months from screening visit)
- Uncontrolled hypertension
- Study Subject has any of the following pulmonary diseases:
- Severe COPD
- Pulmonary fibrosis
- History of recent (\<6 months from screening visit) pulmonary embolism or DVT
- Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:
- Diabetes Mellitus
- Rheumatoid Arthritis
- Lupus
- Multiple Sclerosis
- Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
- Study subject has a history of cancer within 5 years of screening visit (unless curatively treated and without recurrence)
- Study subject has known alcoholic addiction or dependency or has current substance use or abuse.
- 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.
- 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.
- Study subject unable to understand and provide signed informed consent.
- Study subject unlikely to complete the study or adhere to the study procedures.
- Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
- Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hope Biosciences Research Foundation
Sugar Land, Texas, 77478
David Gonzalez, RN, 346-900-0340 ext. 101, david@hopebio.org
Thanh Cheng, MD
About this study
Official title: A Randomized, Double-Blind, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Crohn's Disease
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
Read the detailed description
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).
- To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in fecal calprotectin (FC) values. (Time Frame: Week 0 to Week 52). Clinically significant changes in fecal calprotectin (FC) values are defined as a ≥50% reduction in fecal calprotectin concentration from baseline, or a decrease to <250 µg/g, whichever is achieved first.
Exploratory Objectives:
- To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in CRP values. (Time Frame: Week 0 to Week 52).
- To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in ESR values. (Time Frame: Week 0 to Week 52).
- Conditions
- Crohn Disease (CD)
- Being tested
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells, 0.9% sodium chloride
- Keywords
- Crohn's, Crohn's Disease, Autoimmune, CD, IBD, Inflammatory bowel disease, biologic, stem cell
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem CellsDrug
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 chlorideDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic adipose-derived HB-adMSCs | Experimental | Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells), Intravenous Receives: Drug: HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells |
| 0.9% sodium chloride | Placebo comparator | 0.9% sodium chloride, Intravenous Receives: Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Secondary outcomes (36)
Incidence of serious adverse events (SAEs).
Incidence of serious adverse events (SAEs).
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
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).
Measured: 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
Incidence and risk of AEs of particular interest (serious or non serious), including thromboembolic events, infections, and hypersensitivities.
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
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)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (pg)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (pg)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (fL)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (fL)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Clinically significant changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Clinically significant changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Respiratory Rate (Breaths per minute)
Clinically significant changes from baseline in Respiratory Rate (Breaths per minute)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Heart Rate (Breaths per minute)
Clinically significant changes from baseline in Heart Rate (Breaths per minute)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Body Temperature (Celsius)
Clinically significant changes from baseline in Body Temperature (Celsius)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Systolic Blood Pressure (mmHg)
Clinically significant changes from baseline in Systolic Blood Pressure (mmHg)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Diastolic Blood Pressure (mmHg
Clinically significant changes from baseline in Diastolic Blood Pressure (mmHg)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - SPO2 (%)
Clinically significant changes from baseline in SPO2 (%)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes in Weight results (in kg)
Clinically significant changes in weight (kg)
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Abdomen
Number of participants with abnormal physical examination results - Abdomen
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Cardiovascular
Number of participants with abnormal physical examination results - Cardiovascular
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Lymph Node
Number of participants with abnormal physical examination results - Lymph Node
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Musculoskeletal
Number of participants with abnormal physical examination results - Musculoskeletal
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Neurological
Number of participants with abnormal physical examination results - Neurological
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Respiratory
Number of participants with abnormal physical examination results - Respiratory
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Skin
Number of participants with abnormal physical examination results - Skin
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Change from Baseline in Fecal Calprotectin (FC) values.
Clinically significant changes in Fecal Calprotectin (FC) values, defined as a ≥50% reduction in fecal calprotectin concentration from baseline, or a decrease to <250 µg/g, whichever is achieved first.
Measured: Week 0 (Visit 1) to Week 52 (Visit 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start14 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thanh Cheng, MD, Principal investigator, Hope Biosciences Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077746
- Sponsor's protocol ID
- HBCD01
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Crohn's Disease
- ClinicalTrials.gov ID
- NCT07077746
- Acronym / sponsor ID
- HBCD01
- Conditions
- Crohn Disease (CD)
- Keywords
- Crohn's, Crohn's Disease, Autoimmune, CD, IBD, Inflammatory bowel disease, biologic, stem cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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).
- To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in fecal calprotectin (FC) values. (Time Frame: Week 0 to Week 52). Clinically significant changes in fecal calprotectin (FC) values are defined as a ≥50% reduction in fecal calprotectin concentration from baseline, or a decrease to <250 µg/g, whichever is achieved first.
Exploratory Objectives:
- To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in CRP values. (Time Frame: Week 0 to Week 52).
- To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in ESR values. (Time Frame: Week 0 to Week 52).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Allogeneic adipose-derived HB-adMSCs | Experimental | Drug: HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem CellsAllogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells), Intravenous |
| 0.9% sodium chloride | Placebo comparator | Drug: 0.9% sodium chloride0.9% sodium chloride, Intravenous |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- 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).
Key exclusion criteria (35 listed)
- Study subject has any of the following laboratory results at the screening visit:
- Study subject has CDAI scores of \< 150 or \> 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:
- Study Subject has any of the following pulmonary diseases:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem CellsAllogeneic 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). | Drug | Allogeneic adipose-derived HB-adMSCs |
| 0.9% sodium chloride0.9% 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). | Drug | 0.9% sodium chloride |
Primary outcome
Changes from Baseline in Crohns Disease Activity Index (CDAI) Scores.
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
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.
36 secondary outcomes
Incidence of serious adverse events (SAEs).
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: 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
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
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)
Changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (pg)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (fL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Respiratory Rate (Breaths per minute)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Heart Rate (Breaths per minute)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Body Temperature (Celsius)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Systolic Blood Pressure (mmHg)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - Diastolic Blood Pressure (mmHg
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline in Vital Signs - SPO2 (%)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes in Weight results (in kg)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Abdomen
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Cardiovascular
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Lymph Node
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Musculoskeletal
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Neurological
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Respiratory
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Skin
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Change from Baseline in Fecal Calprotectin (FC) values.
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Related trials for Crohn Disease (CD)
RecruitingPhase 4
Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
Crohn Disease
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Active, not recruitingPhase 4
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Crohn's Disease
RecruitingObservational study
Virtual hIStology of Crohn's Disease Ex-vivo Resected Anatomical Lesions
Crohn Disease (CD)
Recruiting
Impact of Ultra-Processed Food Reduction on Remission Duration in Pediatric Crohn's Disease
Crohn Disease (CD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thanh Cheng, MD principal investigator
Hope Biosciences Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells and 0.9% sodium chloride in people with Crohn Disease (CD), run by Hope Biosciences Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Gonzalez, RN (346-900-0340, david@hopebio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in Crohns Disease Activity Index (CDAI) Scores. (time frame: Week 0 (Visit 1) to Week 52 (Visit 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.