Status:
UNKNOWN
Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia
Lead Sponsor:
National University of Malaysia
Collaborating Sponsors:
Cytopeutics Sdn. Bhd.
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular aut...
Detailed Description
When the long blood vessels supplying blood to the arms and legs become blocked (ischemic), patient will experience painful sensations in their calves when they walked which slowly become excruciating...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01456819
Start Date
March 1 2011
End Date
February 1 2016
Last Update
April 10 2015
Active Locations (1)
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1
UKM Medical Centre
Kuala Lumpur, Malaysia, 56000