Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
Primary Purpose
Kidney Transplant, Chronic Allograft Nephropathy
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
mesenchymal stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplant focused on measuring Kidney Transplant, Chronic Allograft Nephropathy, Mesenchymal Stem Cell infusion
Eligibility Criteria
Inclusion Criteria:
- Recipients of a renal allograft, Male and female patients age 18 to 60 years of age.
- Ability to provide written informed consent.
- The serum creatinine form 176umol/L(2mg/ml) to 440umol/L(5mg/ml)
- Renal biopsy Criteria: chronic allograft nephropathy (Banff I-II).
- Immunosuppressant:CNI and MMF and Sirolimus
- Written informed consent, compliant with local regulations.
Exclusion Criteria:
- Recipients with leucopenia (WBC < 3000/mm³), thrombocytopenia (Thr < 100.000/mm³),or hyperlipidemia (Tot Chol > 300 mg/dl or Triglycerides > 300 mg/dl).
- Recipients of multiple organs.
- Pregnant women.
- Previous history of malignancy
- Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
- Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
- Inadequate compliance to treatment.
Sites / Locations
- Fuzhou General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
transplantation of mesenchymal stem cell
Outcomes
Primary Outcome Measures
Creatinine and creatinine clearance rate
Secondary Outcome Measures
Patient and graft survival [ Time Frame: At 1 years post-transplant ].
The proportion of renal biopsy after 12 months
The incidence of infectious complications
Incidence of adverse events associated with MSC and immunosuppression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00659620
Brief Title
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
Official Title
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2008 (Anticipated)
Study Completion Date
May 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fuzhou General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing properties. the investigators will infuse expanded MSC into patients who develop Chronic Allograft Nephropathy. The purpose of this study is to find out MSC is more effective in preventing organ rejection and maintaining kidney function.
Detailed Description
Kidney transplantation is a common procedure in hospitals, but organ rejection and chronic nephrotoxicity are potential problems for the patient. Approximately ninety percent of the protocol biopsies of renal allografts, performed at 18 months post transplantation, show histological lesions of chronic calcineurin nephrotoxicity. Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Some patient in this study will also receive two infusions of expanded MSC. This study will evaluate the safety and effectiveness of MSC infusions in patients .
This study will last 2 years. Participants will be randomly assigned to receive either the full immunosuppressive therapy and MSC infusions (Group 1) or immunosuppressive therapy alone (Group 2). Patients will undergo MSC infusions at the start of the study on Day 0. One year post- infusions, patients will be evaluated. At Months 12 participants will undergo kidney biopsies. Blood collection will occur at regular intervals, Serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant, Chronic Allograft Nephropathy
Keywords
Kidney Transplant, Chronic Allograft Nephropathy, Mesenchymal Stem Cell infusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
transplantation of mesenchymal stem cell
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cell
Other Intervention Name(s)
MMF FK506
Intervention Description
transplantation of mesenchymal stem cell
Primary Outcome Measure Information:
Title
Creatinine and creatinine clearance rate
Time Frame
5
Secondary Outcome Measure Information:
Title
Patient and graft survival [ Time Frame: At 1 years post-transplant ].
Time Frame
5
Title
The proportion of renal biopsy after 12 months
Time Frame
2
Title
The incidence of infectious complications
Time Frame
5
Title
Incidence of adverse events associated with MSC and immunosuppression
Time Frame
5
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:
Recipients of a renal allograft, Male and female patients age 18 to 60 years of age.
Ability to provide written informed consent.
The serum creatinine form 176umol/L(2mg/ml) to 440umol/L(5mg/ml)
Renal biopsy Criteria: chronic allograft nephropathy (Banff I-II).
Immunosuppressant:CNI and MMF and Sirolimus
Written informed consent, compliant with local regulations.
Exclusion Criteria:
Recipients with leucopenia (WBC < 3000/mm³), thrombocytopenia (Thr < 100.000/mm³),or hyperlipidemia (Tot Chol > 300 mg/dl or Triglycerides > 300 mg/dl).
Recipients of multiple organs.
Pregnant women.
Previous history of malignancy
Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
Inadequate compliance to treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianming Tan T Jianming, Professor
Phone
008613375918000
Email
DOCTORTJM@YAHOO.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Junqi Guo G Junqi, vicProfessor
Phone
008613960941458
Email
guojunq2002@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Tan T Jianming, professor
Organizational Affiliation
Fuzhou General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuzhou General Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Tan T Jianming, professor
Phone
008613375918000
Email
doctortjm@YAHOO.COM
12. IPD Sharing Statement
Learn more about this trial
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
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