Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Chronic Renal Failure
Recruitment status was: Active, not recruiting
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 abnormally low glomerular filtration rate, which is usually determined indirectly by the creatinine level in blood serum.
CRF that leads to severe illness and requires some form of renal replacement therapy(such as dialysis) is called end-stage renal disease (ESRD). While renal replacement therapies can maintain patients indefinitely and prolong life, the quality of life is severely affected. Renal transplantation increases the survival of patients with stage 5 CKD significantly when compared to other therapeutic options; however, it is associated with an increased short-term mortality (due to complications of the surgery).
In view of the above, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully hence the inadequacy of current treatment modalities and insufficiency of donor organs for transplantation have driven a search for improved methods of dealing with renal failure. The rising concept of cell-based therapeutics has provided a framework around which new approaches are being generated, and its combination with advances in stem cell research stands to bring both fields to clinical fruition. Since CRF affects a large number of these patients who will lose their productive life, stem cell implantation can offer some promise of improved health.
In our present study, we want to evaluate the safety and efficacy (to know / observe for Proof of concept in five indian patients) if any, of autologous bone marrow derived stem cells injected into the Renal Artery in five (initially five patients, can be increased to ten patients after observing the initial results) patients with Chronic Renal Failure.
|Chronic Renal Failure||Other: Autologous bone marrow stem cells||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Use of Autologous Bone Marrow Stem Cell Transplantation in the Treatment of Chronic Renal Failure in 5 Indian Patients - ABMST-CRF Study (Autologous Bone Marrow Stem Cell Transplantation-CRF)|
- Significant clinical improvement in serum creatinine and urine output (improvement in measured GFR by 50%) [ Time Frame: 1 year ]
- Number of patients reporting adverse effects as a measure of safety and tolerability [ Time Frame: 1 year ]
- Improvement in renal biopsy [ Time Frame: 1 year ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
|Experimental: Autologous bone marrow stem cells||
Other: Autologous bone marrow stem cells
Bone marrow stem cells; Single dose; Interventional fluoroscopy-guided injection into the renal artery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152411
|St. Theresa's Hospital|
|Bengaluru, Karnataka, India, 560010|
|Study Director:||Balakrishna S, M.B.B.S||International Stemcell Services Limited|