Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease

Study Overview
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Brief Summary
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This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (ADPKD).

Detailed Description
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The investigators will assess the 18-month safety and potential efficacy of autologous MSCs as therapy for ADPKD. A total of 6 patients with ADPKD IV injection of high doses 2×106 of autologous mesenchymal stem cells / kg their weight, which will be derived from biopsies of their bone marrow. Assessments will be made at 1, 3, 6, 12 and 18 months after cell injection. Changes in GFR rate were evaluated by scan isotope.

Official Title
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Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease

Conditions
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Chronic Renal Failure, Polycystic Kidney Disease

Intervention / Treatment
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* Biological: Intravenous injection autologous mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female ADPKD symptoms ADPKD confirmed with sonography and genetic testing Patient's age between 18 - 60 years GFR GFR 25-60 mL/min/1.73 m2 Ability to understand and willingness to sign consent from Exclusion Criteria: Pregnancy or breastfeeding Associated Cardiovascular disease Diabetes requiring medical intervention Other systemic diseases involving the kidneys, such as cancer, autoimmune diseases, blood diseases, liver disease, etc. Hospitalization due to illness in the last two months Life expectancy of less than two years Any allergies to the ingredients used in the cell culture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cell transplantation<br>Intravenous injection of mesenchymal stem cell in patients with PKD | Biological: Intravenous injection autologous mesenchymal stem cells<br>* Intravenous injection of mesenchymal stem cell in patients with PKD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass formation | Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate (GFR) | Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous mesenchymal stem cells, polycystic kidney disease, intravenous injection, CRF