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临床试验/NCT07077746
NCT07077746招募中2 期

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

Hope Biosciences Research Foundation1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年7月14日最近更新:
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干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
46
试验地点
1
主要终点
Changes from Baseline in Crohns Disease Activity Index (CDAI) Scores.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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
  • •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 &gt; 15 mm/hr. for male subjects or &gt; 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.

排除标准

  • •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)
  • •Uncontrolled hypertension
  • •Study Subject has any of the following pulmonary diseases:
  • •Severe COPD
  • •Pulmonary fibrosis
  • •History of recent (&lt;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
  • •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.

研究组 & 干预措施

0.9% sodium chloride

Placebo Comparator

0.9% sodium chloride, Intravenous

干预措施: 0.9% sodium chloride (Drug)

Allogeneic adipose-derived HB-adMSCs

Experimental

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

干预措施: HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells (Drug)

结局指标

主要结局

Changes from Baseline in Crohns Disease Activity Index (CDAI) Scores.

时间窗: 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.

次要结局

  • 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))
  • Changes from Baseline in laboratory values results - Complete Blood Count (pg)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Complete Blood Count (g/dL)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Complete Blood Count (fL)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)(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)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)(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)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in laboratory values results - Coagulation Panel (Seconds)(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)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in Vital Signs - Respiratory Rate (Breaths per minute)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in Vital Signs - Heart Rate (Breaths per minute)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in Vital Signs - Body Temperature (Celsius)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in Vital Signs - Systolic Blood Pressure (mmHg)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in Vital Signs - Diastolic Blood Pressure (mmHg(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Changes from Baseline in Vital Signs - SPO2 (%)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Clinically significant changes in Weight results (in kg)(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Number of participants with abnormal physical examination results - Abdomen(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Number of participants with abnormal physical examination results - Cardiovascular(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Number of participants with abnormal physical examination results - Lymph Node(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Number of participants with abnormal physical examination results - Musculoskeletal(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Number of participants with abnormal physical examination results - Neurological(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Number of participants with abnormal physical examination results - Respiratory(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Number of participants with abnormal physical examination results - Skin(Week 0 (Visit 1) to Week 52 (Visit 9))
  • Change from Baseline in Fecal Calprotectin (FC) values.(Week 0 (Visit 1) to Week 52 (Visit 9))

研究者

发起方
Hope Biosciences Research Foundation
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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