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

NCT ID: NCT02166489

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Renal Failure Polycystic Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mesenchymal stem cell transplantation

Intravenous injection of mesenchymal stem cell in patients with PKD

Group Type EXPERIMENTAL

Intravenous injection autologous mesenchymal stem cells

Intervention Type BIOLOGICAL

Intravenous injection of mesenchymal stem cell in patients with PKD

Interventions

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Intravenous injection autologous mesenchymal stem cells

Intravenous injection of mesenchymal stem cell in patients with PKD

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute

Atieh Makhlough, MD

Role: STUDY_DIRECTOR

Mazandaran University of Medical Sciences, Mazandaran, Iran.

Reza Moghadasali, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

References

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Makhlough A, Shekarchian S, Moghadasali R, Einollahi B, Hosseini SE, Jaroughi N, Bolurieh T, Baharvand H, Aghdami N. Safety and tolerability of autologous bone marrow mesenchymal stromal cells in ADPKD patients. Stem Cell Res Ther. 2017 May 23;8(1):116. doi: 10.1186/s13287-017-0557-7.

Reference Type DERIVED
PMID: 28535817 (View on PubMed)

Related Links

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Other Identifiers

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Royan-Kidney-003

Identifier Type: -

Identifier Source: org_study_id

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