A phase 1/2a clinical trial to evaluate the safety and efficacy of allogeneic adipose tissue-derived mesenchymal stem cell clusters in patients with critical limb ischemia
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006001
- Lead Sponsor
- S.Biomedics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1) Adults aged 19 or older
2) A person diagnosed with critical limb ischemia due to peripheral artery stenosis or obstructive disease (Rutherford category 4, 5, 6)
3) Patients with critical limb ischemia where symptoms do not improve even after medication treatment for more than 3 months
4) Persons who voluntarily agreed to participate in this clinical study
1) Persons whose life expectancy is less than 6 months
2) Patients who underwent surgery and interventional procedures (percutaneous vascular intervention, vascular reconstruction, etc.) in the same disease within 3 months of screening
3) Patients with indications of interventional procedure or surgery
4) Patients with a history of administration of other cell therapy products
5) Persons who have received systemic immunosuppression treatment within 3 months of screening
6) Persons with a history of a malignant tumor within 5 years of screening
(However, non-metastatic basal cell skin carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix that does not recur for at least 1 year before the registration are excluded)
7) Persons with a hematologic disease with major bleeding or bleeding predisposition within 3 months of screening
8) Women who are pregnant, breastfeeding, or planning to become pregnant during the clinical study period, or men and women of childbearing potential who do not use medically acceptable birth control
9) Persons who participated in another clinical study within 3 months of screening
10) Persons who were administered prohibited concomitant medications related to this clinical study
11) Persons with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than twice the normal upper limit at the time of screening
12) Persons identified with estimated glomerular filtration rate (eGFR) levels < 30 mL/min/1.73 m^2 at the time of screening
13) Persons with a history of allergies or hypersensitivity to the investigational product or its components
14) Persons who are judged to be inadequate to participate in clinical study by other investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in ischemic pain;Changes in pain-free walking distance;Changes in TBI (Toe Brachial Index);Changes in ABI (Ankle Brachial Index);Change in size of the Ulcer;Determination of maximum tolerable dose according to DLT occurrence;Incidence of abnormal laboratory tests results;Treatment-emergent adverse event
- Secondary Outcome Measures
Name Time Method Incidence of abnormal blood pressure;Incidence of abnormal temperature;Incidence of abnormal physical condition