Status:
COMPLETED
Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia
Lead Sponsor:
S.Biomedics Co., Ltd.
Collaborating Sponsors:
Dt&Sanomedics
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial is designed as a Phase 1/2a clinical trial targeting patients with critical limb ischemia. The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to as...
Detailed Description
This clinical trial is designed as a Phase 1/2a clinical trial targeting patients with critical limb ischemia. The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04661644
Start Date
November 4 2020
End Date
July 1 2024
Last Update
August 30 2024
Active Locations (1)
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1
Samsung Medical Center
Seoul, Seoul, South Korea, 06351