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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01456819 |
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Date of registration:
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04/10/2011 |
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Primary sponsor: |
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Public title:
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Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia
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Scientific title:
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Phase II Efficacy Study of Intramuscular Autologous Bone Marrow Mononuclear Cells Plus Mesenchymal Stem Cell Implantation Versus Autologous Bone Marrow Mononuclear Cells Implantation Only in Patients With Chronic Critical Limb Ischemia |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01456819 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Hanafiah Harunarashid, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Hanafiah Harunarashid, MD |
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Address:
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Telephone:
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+60391456208 |
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Email:
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hanafiah@ppukm.ukm.my |
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Affiliation:
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Name:
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Hanafiah Harunarashid, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UKM Medical Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of critical limb ischemia leading to ischemic ulcers in which
amputation is indicated
- Not suitable for, or remain symptomatic despite angioplasty, bypass operation or
collateralization
Exclusion Criteria:
- Contraindication to epidural anesthesia and bone marrow aspiration
- Contraindication to contrast angiography
- Evidence of neoplasia and bone marrow diseases
- Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Patients with a limited life expectancy (< 1 year)
- Patients with myocardial infarction or stroke within 6 months
- Patients with coronary intervention within 6 months
- Renal impairment indicated by serum creatinine greater than two times upper limit of
the normal range
- Liver impairment indicated by serum aspartate transaminase and alanine transaminase
greater than two times upper limit of normal
- Any other co-morbidity which the physician deems as a contraindication to stem cell
transplantation
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Critical Limb Ischemia
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Intervention(s)
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Biological: Mononuclear and mesenchymal stem cells
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Biological: Mononuclear cells
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Primary Outcome(s)
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Change in angiogenesis
[Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months]
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Change in blood supply
[Time Frame: 1 month, 12 months]
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Secondary Outcome(s)
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Change in ulcer size
[Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months]
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Exercise Treadmill Test
[Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months]
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Visual Analog Score
[Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months]
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Secondary ID(s)
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FF-113-2011
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NMRR-11-904-9763
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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