NCT02166489

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

June 14, 2014

Last Update Submit

January 3, 2016

Conditions

Chronic Renal FailurePolycystic Kidney Disease

Keywords

autologous mesenchymal stem cellspolycystic kidney diseaseintravenous injectionCRF

Outcome Measures

Primary Outcomes (1)

  • Mass formation

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

    1 month

Secondary Outcomes (1)

  • Glomerular Filtration Rate (GFR)

    6 months

Study Arms (1)

mesenchymal stem cell transplantation

EXPERIMENTAL

Intravenous injection of mesenchymal stem cell in patients with PKD

Biological: Intravenous injection autologous mesenchymal stem cells

Interventions

Intravenous injection autologous mesenchymal stem cellsBIOLOGICAL

Intravenous injection of mesenchymal stem cell in patients with PKD

mesenchymal stem cell transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 28535817DERIVED

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicPolycystic Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsKidney Diseases, CysticAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Nasser Aghdami, MD,PhD

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

    STUDY DIRECTOR

  • Atieh Makhlough, MD

    Mazandaran University of Medical Sciences, Mazandaran, Iran.

    STUDY DIRECTOR

  • Reza Moghadasali, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2014

First Posted

June 18, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2015-11

Locations

IR(1)