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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006001

Enrollment

Registered

2021-03-16

Start date

2020-11-04

Completion date

Unknown

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell : - IP: Clusters of adipose-derived mesenchymal stem cells - Test Group 1: Low Dose - Test Group 2: High Dose - Single dose - Administration Method: 1 mL is withdrawn fro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Incidence of abnormal blood pressure;Incidence of abnormal temperature;Incidence of abnormal physical condition	—

Countries

Korea, Republic of

Contacts

Public ContactDong-ik Kim

Samsung Medical Center

Outcome results