Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

Kidney Transplant Clinical Trial

Official title:

Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00659620
• Other study ID #: fuzhough0712
• Secondary ID: fuzhough0712
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: April 14, 2008
• Last updated: April 14, 2008
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: April 2008
• Source: Organ Transplant Institute, China
• Contact: Jianming Tan T Jianming, Professor
• Phone: 008613375918000
• Email: DOCTORTJM[@]YAHOO.COM
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Allograft Nephropathy
• Kidney Diseases
• Kidney Transplant

Intervention

Biological:
• mesenchymal stem cell
transplantation of mesenchymal stem cell

Locations

Country	Name	City	State
China	Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine and creatinine clearance rate		5	Yes
Secondary	Patient and graft survival [ Time Frame: At 1 years post-transplant ].		5	Yes
Secondary	The proportion of renal biopsy after 12 months		2	Yes
Secondary	The incidence of infectious complications		5	Yes
Secondary	Incidence of adverse events associated with MSC and immunosuppression		5	Yes