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Background Information
1.Background  
CRIS Registration Number KCT0000194 
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
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number SMC 2010-08-054-002 
Approval Date 2010-11-25 
Institutional Review Board  
Name Samsung Medical Center Institutional Review Board  
Address  
Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Dong-Ik Kim 
- Title proffessor 
- Telephone  
- Affiliation Samsung Medical Center  
- Address  
Contact Person for Public Queries
- Name Dong-Ik Kim 
- Title proffessor 
- Telephone  
- Affiliation Samsung Medical Center  
- Address  
Contact Person for Updating Information
- Name Kyounghwan Roh 
- Title  
- Telephone  
- Affiliation Seoul National University  
- Address  
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Recruiting 
Date of First Enrollment 2011-05-31 
State of First Enrollment 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 Site Samsung Medical Center  
- Recruitment Status Recruiting 
- Date of First Enrollment 2011-05-31 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Adult Stem Cell Research Center 
- Organization Type Others  
- Project ID ASCRC-RA-001 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Adult Stem Cell Research Center 
- Organization Type Others  
Study Summary
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.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
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
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). 
Subject Eligibility 정보
9. Subject  
Condition(s)/Problem(s)
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 80 Year
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  
Outcome Measure(s) 정보
10. Outcome Measure(s)  
Type of Primary Outcome Safety 
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 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration