Status:
UNKNOWN
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Chronic Renal Failure
Lead Sponsor:
International Stemcell Services Limited
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Chronic renal failure (CRF, or "chronic kidney failure", CKF, or "chronic kidney disease", CKD) is a slowly progressive loss of renal function over a period of months or years and defined as an abnorm...
Eligibility Criteria
Inclusion
- Must be able to give voluntary written (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- CKD patients of stage IV and ESRD with age 18 to 65 years.
- Patient should be afebrile 24 hours prior to procedure.
Exclusion
- Women who are pregnant or lactating
- Acute Renal Failure
- Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- Haemoglobin level below 8g %
- Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
- Known bleeding or coagulation disorder.
- Known hematologic disease
- Poorly controlled hypertension
- Evidence of active malignancy within one year prior to randomization.
- Severe skin infection or osteomyelitis - the site of bone marrow aspiration potentially limiting the procedure.
- Have a known allergy to iodinated contrast
- Positive test results for HIV and AIDS complex, HCV, HbsAg and Syphilis.
- History of drug or alcohol abuse
- Patients on immunosuppressive therapy
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01152411
Start Date
February 1 2010
End Date
November 1 2012
Last Update
March 29 2012
Active Locations (1)
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1
St. Theresa's Hospital
Bengaluru, Karnataka, India, 560010