Chronic Kidney Disease
Conditions
Keywords
autologous bone marrow mesenchymal stem cells chronic kidney disease
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.
Interventions
BIOLOGICALIntravenous injection
Intravenous injection of bone marrow derived MSC in patients with CKD.
Sponsors
Royan Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| GFR | 6months | Evaluation the increase of GFR 6 months after cell transplantation with scan isotope . |
Countries
Iran
Outcome results
None listed