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New treatment option for Crohn Disease (CD)
Official title HB-adMSCs for the Treatment of Crohn's Disease
ClinicalTrials.gov ID: NCT07077746
What this study is testing
What is HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells?
HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn disease (cd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male and female people 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...
- 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...
- Histologic Findings within 3 years of screening date: Microscopic examination of tissue biopsies that indicate transmural inflammation with lymphoid...
You likely can't join if
- Study subject has any of the following laboratory results at the screening visit:
- WBC: \ 15000 cells/μL (\ 15 K cells/μL)
- Absolute Neutrophil Count: \<1500 cells/μL
- Sodium: \ 150 mEq/L
- Glucose: \>150 mg/dL (for fasting people)
- Potassium: \ 6 mEq/L
See the full eligibility criteria
Who can join
- Male and female people 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...
- 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
- Must have CDAI scores at the screening visit of ≥ 150 to ≤ 450, indicating Mild or Moderate Crohn's Disease.
- people without a current established treatment for Crohn's Disease, or if being treated, people who are on a stable dose of Crohn's Disease therapy regimen for ≥3 months prior to screening.
- people must be willing to maintain their established treatment for Crohn's Disease (or lack thereof) for the duration of the study. people must acknowledge that they may be removed from participation in the study for...
- people 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 people or \> 20 mm/hr. for female people.
- people 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...
- Female study people 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 people of...
- 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 people if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and...
- 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 people 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.
What rules you out
- Study subject has any of the following laboratory results at the screening visit:
- WBC: \ 15000 cells/μL (\ 15 K cells/μL)
- Absolute Neutrophil Count: \<1500 cells/μL
- Sodium: \ 150 mEq/L
- Glucose: \>150 mg/dL (for fasting people)
- Potassium: \ 6 mEq/L
- BUN: \>25 mg/dL
- Creatinine: \>2 mg/dL
- BUN/Creatinine ratio: \>50
- Study subject has CDAI scores of \ 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 people who plan to donate eggs or undergo in vitro fertilization treatment during the study within 6 months after the last infusion. OR Male people who plan to donate sperm during the study within 6 months after...
The study team makes the final eligibility decision.
Where it's taking place
- Sugar Land, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sugar Land, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.