RECRUITING

HB-adMSCs for the Treatment of Crohn's Disease

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-09

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07077746

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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:. 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.	1. Study subject has any of the following laboratory results at the screening visit: 1. WBC: \<3000 cells/μL OR \>15000 cells/μL (\<3 K cells/μL or \>15 K cells/μL) 2. Absolute Neutrophil Count: \<1500 cells/μL 3. Sodium: \<120 mEq/L OR \>150 mEq/L 4. Glucose: \>150 mg/dL (for fasting subjects) 5. Potassium: \<3.5 mEq/L OR \>6 mEq/L 6. BUN: \>25 mg/dL 7. Creatinine: \>2 mg/dL 8. BUN/Creatinine ratio: \>50 2. Study subject has CDAI scores of \< 150 or \> 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 (\<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 (\<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.

Inclusion Criteria

Exclusion 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:.
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.

1. Study subject has any of the following laboratory results at the screening visit:
1. WBC: \<3000 cells/μL OR \>15000 cells/μL (\<3 K cells/μL or \>15 K cells/μL)
2. Absolute Neutrophil Count: \<1500 cells/μL
3. Sodium: \<120 mEq/L OR \>150 mEq/L
4. Glucose: \>150 mg/dL (for fasting subjects)
5. Potassium: \<3.5 mEq/L OR \>6 mEq/L
6. BUN: \>25 mg/dL
7. Creatinine: \>2 mg/dL
8. BUN/Creatinine ratio: \>50
2. Study subject has CDAI scores of \< 150 or \> 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 (\<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 (\<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.

Contacts and Locations

Study Contact

David Gonzalez, RN

CONTACT

346-900-0340

david@hopebio.org

Principal Investigator

Thanh Cheng, MD

PRINCIPAL_INVESTIGATOR

Hope Biosciences Research Foundation

Study Locations (Sites)

Hope Biosciences Research Foundation

Sugar Land, Texas, 77478

United States

Collaborators and Investigators

Sponsor: Hope Biosciences

Thanh Cheng, MD, PRINCIPAL_INVESTIGATOR, Hope Biosciences Research Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-09

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Crohn Disease (CD)