Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia
NCT ID: NCT04661644
Last Updated: 2024-08-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-11-04
Study Completion Date
2024-07-01
Brief Summary
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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 assess the safety and efficacy of the investigational product(A cluster of adipose-derived mesenchymal stem cells (3D-A) (cluster of adipose- derived mesenchymal stem cells)) and proceeds in that order.
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Detailed Description
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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 assess the safety and efficacy of the investigational product.
Phase 1: Open-label, 3 + 3 design, single-center This phase is conducted in a 3 + 3 design by dose level to evaluate the tolerability of the investigational product.
If the subject voluntarily agrees signs the informed consent formin writing to participate in this clinical trial, the subjects who had necessary check-ups and tests and meet the inclusion criteria after subject conformity assessment are registered in the clinical trial.The subjects receive the investigational product once and are checked for adverse events through day 1 and then discharged. The safety and efficacy assessments are conducted through visits at week 4, week 12, and week 24 after administration.
Subjects are evaluated for adverse events up to week 4 after the administration of the investigational product by registering 3 subjects each at the dosing phase. This evaluation is conducted according to the number of persons subjects who developed Grade 3 or higher adverse drug reactions (ADRs) according to CTCAE Version\_5.0 in which a causal relation with the investigational product cannot be ruled out.
If the maximum tolerated dose (MTD) is determined with the test group 2 (high dose) in the Phase 1 clinical trial, the Phase 2a clinical trial will be conducted with the two groups, test group 2 and test group 1.
However, if adverse events occur in 1 of 6 subjects, the test group 2 will be decided considered as the maximum tolerated dose (MTD), or but only the test group 1 will proceed to Phase 2a.
If adverse events occur in 2 or more subjects out of 6 subjects, a dose smaller than test group 1 (low dose) is determined to be the maximum tolerated dose. The Phase 2a clinical trial will not proceed and the clinical trial will end.
Phase 2a: Open-label, sequential assignment, single-center If tolerability and safety are secured 4 weeks after administration of the investigational product of Phase 1, Phase 2a is conducted.
Only those subjects meeting the final inclusion criteria are sequentially assigned, admitted by the same procedure, and administered the investigational product once. Subjects are checked for adverse events through day 1 and discharged. Safety and efficacy assessments are performed at week 4, week 12, and week 24 after administration. All subjects are tested with the same schedule, excluding their doses.
The subjects enrolled in Phase 1 are analyzed for efficacy through visits at week 12 and week 24 so that all subjects (Phase 1 and Phase 2a) are assessed and analyzed for efficacy.
Phase 1: Open-label, 3 + 3 design, single-center This phase is conducted in a 3 + 3 design by dose level to evaluate the tolerability of the investigational product.
If the subject voluntarily agrees signs the informed consent formin writing to participate in this clinical trial, the subjects who had necessary check-ups and tests and meet the inclusion criteria after subject conformity assessment are registered in the clinical trial.The subjects receive the investigational product once and are checked for adverse events through day 1 and then discharged. The safety and efficacy assessments are conducted through visits at week 4, week 12, and week 24 after administration.
Subjects are evaluated for adverse events up to week 4 after the administration of the investigational product by registering 3 subjects each at the dosing phase. This evaluation is conducted according to the number of persons subjects who developed Grade 3 or higher adverse drug reactions (ADRs) according to CTCAE Version\_5.0 in which a causal relation with the investigational product cannot be ruled out.
If the maximum tolerated dose (MTD) is determined with the test group 2 (high dose) in the Phase 1 clinical trial, the Phase 2a clinical trial will be conducted with the two groups, test group 2 and test group 1.
However, if adverse events occur in 1 of 6 subjects, the test group 2 will be decided considered as the maximum tolerated dose (MTD), or but only the test group 1 will proceed to Phase 2a.
If adverse events occur in 2 or more subjects out of 6 subjects, a dose smaller than test group 1 (low dose) is determined to be the maximum tolerated dose. The Phase 2a clinical trial will not proceed and the clinical trial will end.
Phase 2a: Open-label, sequential assignment, single-center If tolerability and safety are secured 4 weeks after administration of the investigational product of Phase 1, Phase 2a is conducted.
Only those subjects meeting the final inclusion criteria are sequentially assigned, admitted by the same procedure, and administered the investigational product once. Subjects are checked for adverse events through day 1 and discharged. Safety and efficacy assessments are performed at week 4, week 12, and week 24 after administration. All subjects are tested with the same schedule, excluding their doses.
The subjects enrolled in Phase 1 are analyzed for efficacy through visits at week 12 and week 24 so that all subjects (Phase 1 and Phase 2a) are assessed and analyzed for efficacy.
Conditions
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Critical Limb Ischemia
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SEQUENTIAL
Phase 1 is conducted to evaluate the tolerability of the IP Subjects receive the IP once and are checked for adverse events. Subjects are evaluated for adverse events after the administration of the IP by registering 3 subjects each at the dosing phase.
If the maximum tolerated dose (MTD) is determined with the test group 2 (high dose) in the Phase 1, the Phase 2a clinical trial will be conducted. However, if 1 adverse events occur, the test group 2 will be considered as the maximum tolerated dose (MTD), or but only the test group 1 will proceed to Phase 2a.
If 2 adverse events occur, a dose smaller than test group 1 (low dose) is determined to be the maximum tolerated dose. The Phase 2a clinical trial will not proceed and the clinical trial will end.
If tolerability and safety are secured, subjects meeting the final inclusion criteria are assigned to Phase 2a, admitted by the same procedure, and administered the IP once. Safety and efficacy assessments are performed.
If the maximum tolerated dose (MTD) is determined with the test group 2 (high dose) in the Phase 1, the Phase 2a clinical trial will be conducted. However, if 1 adverse events occur, the test group 2 will be considered as the maximum tolerated dose (MTD), or but only the test group 1 will proceed to Phase 2a.
If 2 adverse events occur, a dose smaller than test group 1 (low dose) is determined to be the maximum tolerated dose. The Phase 2a clinical trial will not proceed and the clinical trial will end.
If tolerability and safety are secured, subjects meeting the final inclusion criteria are assigned to Phase 2a, admitted by the same procedure, and administered the IP once. Safety and efficacy assessments are performed.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Test Group 1 (Low 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.
Group Type
EXPERIMENTAL
Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial)
Intervention Type
BIOLOGICAL
Dose: 1 x 10\^7 cells/1 mL/vial (1,000 clusters of adipose-derived mesenchymal stem cells)
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, 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.
Group Type
EXPERIMENTAL
Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)
Intervention Type
BIOLOGICAL
Dose: 1 x 10\^8 cells/1 mL/vial (10,000 clusters of adipose-derived mesenchymal stem cells)
Interventions
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Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial)
Dose: 1 x 10\^7 cells/1 mL/vial (1,000 clusters of adipose-derived mesenchymal stem cells)
Intervention Type
BIOLOGICAL
Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)
Dose: 1 x 10\^8 cells/1 mL/vial (10,000 clusters of adipose-derived mesenchymal stem cells)
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
1. Adults aged 19 or older
2. A person diagnosed with critical limb ischemia due to peripheral artery stenosis or obstructive occlusive 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\[1\]
4. Persons who voluntarily agreed to participate in this clinical trial
2. A person diagnosed with critical limb ischemia due to peripheral artery stenosis or obstructive occlusive 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\[1\]
4. Persons who voluntarily agreed to participate in this clinical trial
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 in need 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 of the skin 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 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.)
9. Persons who participated in other clinical trials within 3 months of screening
10. Persons who were administered prohibited concomitant medications related to this clinical trial
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 m2 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 trials by other investigators
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 in need 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 of the skin 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 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.)
9. Persons who participated in other clinical trials within 3 months of screening
10. Persons who were administered prohibited concomitant medications related to this clinical trial
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 m2 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 trials by other investigators
Minimum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dt&Sanomedics
INDUSTRY
Sponsor Role
collaborator
S.Biomedics Co., Ltd.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Dong-Ik Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, Seoul, South Korea
Site Status
Countries
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South Korea
References
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BACKGROUND
Dubsky M, Husakova J, Sojakova D, Fejfarova V, Jude EB. Cell Therapy of Severe Ischemia in People with Diabetic Foot Ulcers-Do We Have Enough Evidence? Mol Diagn Ther. 2023 Nov;27(6):673-683. doi: 10.1007/s40291-023-00667-w. Epub 2023 Sep 22.
Reference Type
DERIVED
Other Identifiers
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SB-AC-001
Identifier Type: -
Identifier Source: org_study_id
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Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy
NCT03239535
UNKNOWN
PHASE1/PHASE2
Cell Therapy in Critical Limb Ischemia
NCT03994666
UNKNOWN
PHASE2
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
NCT01833585
COMPLETED
PHASE3
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury
NCT02444455
UNKNOWN
PHASE1/PHASE2
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
NCT02099500
WITHDRAWN
PHASE1
Cell Therapy in Chronic Limb Ischemia
NCT00533104
COMPLETED
PHASE1/PHASE2
Safety and Feasibility Study of Administration of Mesenchymal Stemcells for Treatment of Emphysema
NCT01306513
COMPLETED
PHASE1
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
NCT01472289
COMPLETED
PHASE1/PHASE2
The STem Cell Application Researches and Trials In NeuroloGy-2 (STARTING-2) Study
NCT01716481
UNKNOWN
PHASE3
Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia
NCT05631444
COMPLETED
PHASE1/PHASE2
Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
NCT01558908
UNKNOWN
PHASE1/PHASE2
Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
NCT00955669
COMPLETED
PHASE1
Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.
NCT03968198
TERMINATED
PHASE2
Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
NCT01211028
COMPLETED
PHASE1/PHASE2
Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia
NCT00434616
UNKNOWN
PHASE2/PHASE3
Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
NCT00518401
COMPLETED
PHASE1
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
NCT05854615
RECRUITING
PHASE4