Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
Primary Purpose
Chronic Renal Failure, Polycystic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intravenous injection autologous mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure focused on measuring autologous mesenchymal stem cells, polycystic kidney disease, intravenous injection, CRF
Eligibility Criteria
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
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mesenchymal stem cell transplantation
Arm Description
Intravenous injection of mesenchymal stem cell in patients with PKD
Outcomes
Primary Outcome Measures
Mass formation
Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.
Secondary Outcome Measures
Glomerular Filtration Rate (GFR)
Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02166489
Brief Title
Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
Official Title
Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, Polycystic Kidney Disease
Keywords
autologous mesenchymal stem cells, polycystic kidney disease, intravenous injection, CRF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mesenchymal stem cell transplantation
Arm Type
Experimental
Arm Description
Intravenous injection of mesenchymal stem cell in patients with PKD
Intervention Type
Biological
Intervention Name(s)
Intravenous injection autologous mesenchymal stem cells
Intervention Description
Intravenous injection of mesenchymal stem cell in patients with PKD
Primary Outcome Measure Information:
Title
Mass formation
Description
Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Glomerular Filtration Rate (GFR)
Description
Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Atieh Makhlough, MD
Organizational Affiliation
Mazandaran University of Medical Sciences, Mazandaran, Iran.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Reza Moghadasali, PhD
Organizational Affiliation
Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28535817
Citation
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.
Results Reference
derived
Links:
URL
http://Royaninstitute.org
Description
Related Info
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Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
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