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

Chronic Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166489
• Other study ID #: Royan-Kidney-003
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2014
• Last updated: January 3, 2016
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2015
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Diseases
• Kidney Failure, Chronic
• Polycystic Kidney Disease
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant
• Renal Insufficiency

Intervention

Biological:
• Intravenous injection autologous mesenchymal stem cells
Intravenous injection of mesenchymal stem cell in patients with PKD

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass formation	Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.	1 month	Yes
Secondary	Glomerular Filtration Rate (GFR)	Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.	6 months	Yes

External Links

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