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

January 3, 2016 updated by: Royan Institute

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mesenchymal stem cell transplantation
Intravenous injection of mesenchymal stem cell in patients with PKD
Biological: Intravenous injection autologous mesenchymal stem cells
Intravenous injection of mesenchymal stem cell in patients with PKD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mass formation
Time Frame: 1 month
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)
Time Frame: 6 months
Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Study Director: Atieh Makhlough, MD, Mazandaran University of Medical Sciences, Mazandaran, Iran.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 14, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 3, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Kidney-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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