Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
- Conditions
- Chronic Kidney Disease
- Interventions
- Biological: Intravenous injection
- Registration Number
- NCT02195323
- Lead Sponsor
- Royan Institute
- Brief Summary
This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).
- Detailed Description
We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) were evaluated by scan isotope.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Male and Female
- CKD symptoms
- CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
- Patient's age between 25 - 60 years
- Ability to understand and willingness to sign consent from
- Pregnant or lactating
- Basis disease such as diabetes, malignancy and autoimmune
- Unable to follow post-operative exercise regimen or return for evaluations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MSC recipient Intravenous injection The patients with CKD who underwent intravenous injection of MSC.
- Primary Outcome Measures
Name Time Method mass formation 6months Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.
Creatinin 1 month Evaluation the rise of creatinin 1 month after cell transplantation.
- Secondary Outcome Measures
Name Time Method GFR 6months Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .
Trial Locations
- Locations (1)
Royan Institute
🇮🇷Tehran, Iran, Islamic Republic of