Status Approved
First Submitted Date
2011/08/03
Registered Date
2011/10/05
Last Updated Date
2011/10/05
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0000194 |
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Unique Protocol ID | SMC 2010-08-054-002 |
Public/Brief Title | The Study of Human Cord Blood-derived Mesenchymal Stem Cells Therapy in Ischemic Limb Disease |
Scientific Title | The Safety of Human Cord Blood-derived Mesenchymal Stem Cells Therapy in Patients with Peripheral Arterial Occlusive Disease:Phase 1 Clinical Study |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | SMC 2010-08-054-002 |
Approval Date | 2010-11-25 |
Institutional Review Board Name | Samsung Medical Center Institutional Review Board |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Dong-Ik Kim |
Title | proffessor |
Telephone | +82-2-3410-3467 |
Affiliation | Samsung Medical Center |
Address | |
Contact Person for Public Queries | |
Name | Dong-Ik Kim |
Title | proffessor |
Telephone | +82-2-3410-3467 |
Affiliation | Samsung Medical Center |
Address | |
Contact Person for Updating Information | |
Name | Kyounghwan Roh |
Title | |
Telephone | +82-2-880-1298 |
Affiliation | Seoul National University |
Address |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2011-05-31 Actual | |
Target Number of Participant | 10 | |
Primary Completion Date | 2012-04-30 , Anticipated | |
Study Completion Date | 2012-07-30 | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2011-05-31 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Adult Stem Cell Research Center |
Organization Type | Others |
Project ID | ASCRC-RA-001 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Adult Stem Cell Research Center |
Organization Type | Others |
7. Study Summary
Lay Summary | The Safety of allogenic umbilical cord blood-derived mesenchymal stem cells therapy in patient with peripheral arterial occlusive disease: Phase I Clinical study. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase1 |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | /Biological/Vaccine |
Intervention Description | - Dose : 1x10^7 cells/injection - Injection Route : inject to 20 different sites arround tibial artery and fibular artery which situated below the knee joint of ischemic limb - Injection : 1 times |
Number of Arms | 1 |
Arm 1 |
Arm Label Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cells Injection Group |
Target Number of Participant 10 |
|
Arm Type Experimental |
|
Arm Description In patient with Peripheral Arterial Occlusive Disease, we treat 1x10^7 human Umbilical Cord Blood-derived Mesenchymal Stem Cells one times. Injection Route is ischemic limb area below knee joint, and we inject by intramuscle(IM). |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I74.3)Embolism and thrombosis of arteries of lower extremities |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~80Year |
|
Description 1) Among the patients who has Peripheral arterial occlusive disease caused by Buerger's disease and arteriosclerosis and at the same time their ABI (resting ankle-brachial index) is lower than 0.9 follow by hemodynamical definition. (1) Rutherford’s (Fontaine’s stages IIb, III, IV) 3, 4, 5, and 6 (reference 12) patient who has at least 3months claudification or pain during a rest or gangrene or ulcer with irrespective period. (but, patient who does not get better with medication and improvement of life style during 3months will be a candidate for Category 3) (2) patient who is Inapplicable by Bypass surgery or percutaneous transluminal angioplasty; In case of patients with bypass surgery or percutaneous transluminal angioplasty cannot be applied; By doctors from Vascular surgery, cardiovascular medicine, and department of radiology determines bypass surgy and percutaneous transluminal angioplasty is not applicable through reffering system. 2) Person who agree to the agreement by themselves by fully explained about purpose, content and charateristic of trial medicine before participate |
|
Exclusion Criteria |
(1) Under 18 (2) Medical history of allergy or anaphylatic shock (3) Medical history of Autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, ....)or Hypercoagulated disease (4) Having the bypass surgery or angioplasty of artery or aorta within first two months of visit (5) Medical history of being treated with other cell therapy of gene therapy (6) Having a Heart failure of NYHA functional classification III & IV (reference 13) (7) Having unstable angina (8) Medical history of acute ST-segment elevation with myocardial infarction within a first month of visit (9) Medical history of transient ischemic attack or stroke within a first month of visit (10) Severe valvular heart disease (11) Uncontrolled diabetes (HbA1c > 8%) (12) Renal failure (creatinine > 2.5) (13) Medical history of having malignant tumor or being treated with radiation therapy or chemotherapy within five years (14) Pregnant or lactating or possible pregnancy women who is free to medically accepted method of birth control (15) Having cognitive dysfunction and walking disability (16) Having infectious disease (17) Severe disease patient who might die during follow-up period because of their one year life expectancy (18) WBC < 4,000 or WBC > 15,000 (19) AST (GOT) > 100 or ALT (GPT) > 100 (20) Having gait disturbance by neurology cause (21) Disqualified as a suitable subjest by tester (22) Uncontrolled hypertension (23) Currently receiving immunosuppressive therapy or chemical therapy (24) Hematodyscrasia patient with hemorragic diathresis (25) Participated in other clinical trials (26) Patient with Hb<10 and thrombocyte<100,000 |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Safety | |
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Primary Outcome(s) 1 | ||
Outcome | Adverse Effect |
|
Timepoint | During treatment period |
|
Secondary Outcome(s) 1 | ||
Outcome | Scale for gauging changes in clinical status |
|
Timepoint | During treatment period |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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