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Study was stopped by sponsers internal reason.
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This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability.
A participant that satisfies all inclusion and exclusion criteria is assigned a test group(2-time injection group).
Participants conduct cell therapy within 30 days after bone marrow aspiration, and will re-inject autologous mesenchymal stem cells within 30 days after first injection.
Participants will make a total of 5 hospital visits after registration, and Safety and Efficacy will be evaluated based on a fixed procedure on every visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-time injection group : Cellgram-CLI | Experimental | Within 30 days after extracting bone marrow, autologous bone marrow-derived mesenchymal stem cells is directly injected into the lesion. Then the second cell is injected within 30 days after the first cell injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellgram-CLI | Drug | Appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip Main ingredient: Autologous bone marrow-derived mesenchymal stem cells Dosage: 50,000,000 cells/10ml, 2-time injection Storage: An airtight container, 20~25℃ Injection Method: Intramuscular |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Brachial Pressure Index, ABPI | Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of between the two visits(Screening and 6 month post treatment) before and after treatment. | 6 months after BM-MSC therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Collateral vessel formation on digital subtraction angiography (DSA) | Analyze the difference of pre and post treatment using McNemar test for homogeneity test. | 6 months after BM-MSC therapy |
| Difference of Wound size |
| Measure | Description | Time Frame |
|---|---|---|
| For safety analysis we will observed clinical laboratory tests, physical examinations, tumor marker tests | Analyze using McNemar's test by making a table of changes that occurred in the test. clinical laboratory tests(Follow the unit of each institution): <Blood>
physical examinations: -Allergy, Cardiovascular, Respiratory, Gastrointestinal /Liver biliary, Metabolic / endocrine, Kidney / urinary system, Reproductive, Musculoskeletal, Skin and connective, Nervous, Psyatric, Others tumor marker tests(Follow the unit of each institution):
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| WoongChol Kang, MD, Ph.D | Gachon University Gil Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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|
|
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post treatment Healing of ulcerations (change in size of ulcers) or reduction of ulcer area in the target limb.
| 6 months after BM-MSC therapy |
| Improved transcutaneous oxygen pressure (TCPO2) | Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post treatment transcutaneous oxygen pressure (TCPO2). | 6 months after BM-MSC therapy |
| Pain on the Visual Analogue Scale(VAS) | Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post Visual Analogue Scale(VAS). Visual Analogue Scale(VAS): Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) | 6 months after BM-MSC therapy |
| Reduced limb amputation | Described and define as minor amputation is below midtarsal level, major amputation is more than midtarsal level. | 6 months after BM-MSC therapy |
| Temperature change on thermography | Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post thermography. | 6 months after BM-MSC therapy |
| Dose about using analgesic medicine | Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference between pre and post dose of the using analgesic medicine. | 6 months after BM-MSC therapy |
| Change in Rutherford classification | Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post Rutherford classification. Rutherford classification: commonly used clinical staging system for describing peripheral arterial disease. Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene | 6 months after BM-MSC therapy |
| Frequency about using analgesic medicine | Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference between pre and post frequency of the using analgesic medicine. | 6 months after BM-MSC therapy |
| 12 months after BM-MSC therapy |
| occurrence and severity of adverse events | Analyze the adverse events by using seriousness, severity and relevance of IP. | 12 months after BM-MSC therapy |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |