Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

NCT00659620 | Unknown Phase 1 DMC

• 1 other identifier: fuzhough0712
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Chronic Allograft Nephropathy

Keywords

Kidney Transplant; Chronic Allograft Nephropathy; Mesenchymal Stem Cell infusion

Outcome Measures

Primary Outcomes (1)

• Creatinine and creatinine clearance rate

  5

Secondary Outcomes (4)

• Patient and graft survival [ Time Frame: At 1 years post-transplant ].

  5

• The proportion of renal biopsy after 12 months

  2

• The incidence of infectious complications

  5

• Incidence of adverse events associated with MSC and immunosuppression

  5

Study Arms (1)

1

EXPERIMENTAL

transplantation of mesenchymal stem cell

Biological: mesenchymal stem cell

Interventions

mesenchymal stem cell BIOLOGICAL

transplantation of mesenchymal stem cell

Also known as: MMF FK506

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

Location

Study Officials

• Jianming Tan T Jianming, professor

  Fuzhou General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianming Tan T Jianming, Professor

CONTACT

008613375918000; DOCTORTJM@YAHOO.COM

Junqi Guo G Junqi, vicProfessor

CONTACT

008613960941458; guojunq2002@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 16, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2010
• Last Updated: April 16, 2008

Record last verified: 2008-04

Locations

CN (1)