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NCT Number: NCT02166489

Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to 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).

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Key information

Conditions

Chronic Renal Failure Abnormalities, Multiple Chronic Disease Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Polycystic Kidney Disease Polycystic Kidney Diseases Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous injection autologous mesenchymal stem cells

Biological

Intravenous injection of mesenchymal stem cell in patients with PKD

Primary outcomes

  1. Mass formation

    Time frame: 1 month

    Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.

Secondary outcomes

  1. Glomerular Filtration Rate (GFR)

    Time frame: 6 months

    Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 18, 2014
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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