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

Royan Institute

Status and phase

Completed

Phase 1

Conditions

Polycystic Kidney Disease

Chronic Renal Failure

Treatments

Biological: Intravenous injection autologous mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02166489

Royan-Kidney-003

Details and patient eligibility

About

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).

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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