Clinical trial NCT00659620: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Kidney Transplant
Chronic Allograft Nephropathy
Keywords: Kidney Transplant
Chronic Allograft Nephropathy
Mesenchymal Stem Cell infusion
Lead sponsor: Organ Transplant Institute, China
Sponsor class: OTHER_GOV
First posted: 2008-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Creatinine and creatinine clearance rate
timeFrame: 5
Secondary outcomes:
measure: Patient and graft survival [ Time Frame: At 1 years post-transplant ].
timeFrame: 5
measure: The proportion of renal biopsy after 12 months
timeFrame: 2
measure: The incidence of infectious complications
timeFrame: 5
measure: Incidence of adverse events associated with MSC and immunosuppression
timeFrame: 5
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital
state: Fujian
Study officials:
affiliation: Fuzhou General Hospital
name: Jianming Tan T Jianming, professor
role: PRINCIPAL_INVESTIGATOR
References: