Safety and Efficacy of Autologous bone marrow stem cells for treatment of Chronic Renal Failure
- Registration Number
- CTRI/2010/091/001048
- Lead Sponsor
- International Stemcell Services Limited117, Venkateshwara Nagar, Jakkur, Bengaluru 560064
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 5
1. Must be able to give voluntary written (patients may not be able to write) consent.
2. Must be able to understand study information provided to him.
3. CKD patients of stage IV and ESRD with age 18 to 65 years.
4. Patient should be afebrile 24 hours prior to procedure.
1.Women who are pregnant or lactating
2.Acute Renal Failure
3.Severe co-morbidities like cardiac insufficiency, congestive cardicac failure, malignancy, infection, sepsis and bed sores.
4.Haemoglobin level below 8g %
5.Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
6.Known bleeding or coagulation disorder
7.Known hematologic disease
8.Poorly controlled hypertension
9.Evidence of active malignancy within one year prior to randomization.
10.Severe skin infection or osteomyelitis - the site of bone marrow aspiration potentially limiting the procedure.
11.Have a known allergy to iodinated contrast
12.Positive test results for HIV and AIDS complex.
13.History of drug or alcohol abuse
14.Patients on immunosuppressive therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To establish safety of stem cell therapy in patients with chronic renal failure.<br>2.To assess short and long term efficacy of stem cell therapy in chronic renal failure.Timepoint: 3 months, 6 months, 1 year
- Secondary Outcome Measures
Name Time Method Improvement in renal biopsy.Timepoint: 6 months, 1 year