CTRI/2010/091/001048
Recruiting
Phase 1
se of Autologous bone marrow stem cell transplantation therapy in the treatment of Chronic Renal Failure in 5 indian patients. ABMST-CRF Study (Autologous Bone marrow Stem cell Transplantation-CRF).
International Stemcell Services Limited117, Venkateshwara Nagar, Jakkur, Bengaluru 5600640 sites5 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- International Stemcell Services Limited117, Venkateshwara Nagar, Jakkur, Bengaluru 560064
- Enrollment
- 5
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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