Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Royan Institute
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Creatinin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Pregnant or lactating
- •Basis disease such as diabetes, malignancy and autoimmune
- •Unable to follow post-operative exercise regimen or return for evaluations
Arms & Interventions
MSC recipient
The patients with CKD who underwent intravenous injection of MSC.
Intervention: Intravenous injection (Biological)
Outcomes
Primary Outcomes
Creatinin
Time Frame: 1 month
Evaluation the rise of creatinin 1 month after cell transplantation.
mass formation
Time Frame: 6months
Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.
Secondary Outcomes
- GFR(6months)