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

Phase 1

Completed

• Conditions: Polycystic Kidney Disease; Chronic Renal Failure
• Interventions: Biological: Intravenous injection autologous mesenchymal stem cells

• Registration Number: NCT02166489
• Lead Sponsor: Royan Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-14
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-18
• Status Verified: 2015-11
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-03
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cell transplantation	Intravenous injection autologous mesenchymal stem cells	Intravenous injection of mesenchymal stem cell in patients with PKD

Primary Outcome Measures

Name	Time	Method
Mass formation	1 month	Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.

Secondary Outcome Measures

Name	Time	Method
Glomerular Filtration Rate (GFR)	6 months	Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of