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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02166489

Enrollment

Registered

2014-06-18

Start date

2014-03-31

Completion date

2016-01-31

Last updated

2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure, Polycystic Kidney Disease

Keywords

autologous mesenchymal stem cells, polycystic kidney disease, intravenous injection, CRF

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.

Interventions

BIOLOGICALIntravenous injection autologous mesenchymal stem cells

Intravenous injection of mesenchymal stem cell in patients with PKD

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026