Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients With Critical Limb Ischemia
Critical Limb Ischemia
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Adipose-derived mesenchymal stem cells, Critical limb ischemia, Stem cells, Ischemia, S.Biomedics
Eligibility Criteria
Inclusion Criteria:
- Adults aged 19 or older
- A person diagnosed with critical limb ischemia due to peripheral artery stenosis or obstructive occlusive disease (Rutherford category 4, 5, 6)
- Patients with critical limb ischemia where symptoms do not improve even after medication treatment for more than 3 months[1]
- Persons who voluntarily agreed to participate in this clinical trial
Exclusion Criteria:
- Persons whose life expectancy is less than 6 months
- Patients who underwent surgery and interventional procedures (percutaneous vascular intervention, vascular reconstruction, etc.) in the same disease within 3 months of screening
- Patients in need of interventional procedure or surgery
- Patients with a history of administration of other cell therapy products
- Persons who have received systemic immunosuppression treatment within 3 months of screening
- Persons with a history of a malignant tumor within 5 years of screening (However, non-metastatic basal cell skin carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that does not recur for at least 1 year before the registration are excluded)
- Persons with a hematologic disease with major bleeding or bleeding predisposition within 3 months of screening
Women who are pregnant, breastfeeding or planning to become pregnant during the clinical trial period or women of childbearing potential who do not use medically acceptable birth control
*Medically acceptable contraception:
- Medicine: Oral contraceptives, skin patches or progestin medications (Transplant or injection)
- Diaphragm: Condoms, diaphragms, intrauterine devices (IUDs), vaginal suppositories
- Abstinence: Absolute abstinence (However, periodic abstinence (e.g., calendar method, ovulation method, sympto-thermal method) and control are not considered acceptable contraceptive methods.)
- Persons who participated in other clinical trials within 3 months of screening
- Persons who were administered prohibited concomitant medications related to this clinical trial
- Persons with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than twice the normal upper limit at the time of screening
- Persons identified with estimated glomerular filtration rate (eGFR) levels < 30 mL/min/1.73 m2 at the time of screening
- Persons with a history of allergies or hypersensitivity to the investigational product or its components
- Persons who are judged to be inadequate to participate in clinical trials by other investigators
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Test Group 1 (Low Dose)
Test Group 2 (High Dose)
- Administration Method: 1 mL is withdrawn from 1 vial of clusters of adipose-derived mesenchymal stem cells, composed of adipose-derived mesenchymal stem cells and diluted with 20 mL of saline, which is divided into 1 cc pre-filled syringes and administered in 20 divided doses to 15-20 parts of the muscle in divided doses along the working areacourse of the tibial artery and peroneal artery below the knee joint (above the lower ischemic area) of the subject (above the lower ischemic area) of the subjects under general anesthesia or spinal anesthesia so that the entire diluted solution is administered.
- Administration Method: 1 mL is withdrawn from 1 vial of clusters of adipose-derived mesenchymal stem cells, composed of adipose-derived mesenchymal stem cells and diluted with 20 mL of saline, then administered to 15-20 parts of the muscle along the working areacourse of the tibial artery and peroneal artery below the knee joint (above the lower ischemic area) of the subject (above the lower ischemic area) of the subjects under general anesthesia or spinal anesthesia.