Back to resultsAutologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intravenous injection
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring autologous bone marrow mesenchymal stem cells chronic kidney disease
Eligibility Criteria
Inclusion Criteria:
- Male and Female
- CKD symptoms
- CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
- Patient's age between 25 - 60 years
- Ability to understand and willingness to sign consent from
Exclusion Criteria:
- Pregnant or lactating
- Basis disease such as diabetes, malignancy and autoimmune
- Unable to follow post-operative exercise regimen or return for evaluations
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MSC recipient
Arm Description
The patients with CKD who underwent intravenous injection of MSC.
Outcomes
Primary Outcome Measures
mass formation
Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.
Creatinin
Evaluation the rise of creatinin 1 month after cell transplantation.
Secondary Outcome Measures
GFR
Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02195323
Brief Title
Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
Official Title
Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 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 kidney disease (CKD).
Detailed Description
We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) 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 Kidney Disease
Keywords
autologous bone marrow mesenchymal stem cells chronic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MSC recipient
Arm Type
Experimental
Arm Description
The patients with CKD who underwent intravenous injection of MSC.
Intervention Type
Biological
Intervention Name(s)
Intravenous injection
Other Intervention Name(s)
Intravenous transplantation
Intervention Description
Intravenous injection of bone marrow derived MSC in patients with CKD.
Primary Outcome Measure Information:
Title
mass formation
Description
Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.
Time Frame
6months
Title
Creatinin
Description
Evaluation the rise of creatinin 1 month after cell transplantation.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
GFR
Description
Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .
Time Frame
6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and Female
CKD symptoms
CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
Patient's age between 25 - 60 years
Ability to understand and willingness to sign consent from
Exclusion Criteria:
Pregnant or lactating
Basis disease such as diabetes, malignancy and autoimmune
Unable to follow post-operative exercise regimen or return for evaluations
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 regenerative medicine department &cell therapy center of Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Atieh Makhloogh, 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
Links:
URL
http://Royaninstitute.org
Description
Related Info
Learn more about this trial
Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
We'll reach out to this number within 24 hrs