Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus

November 1, 2013 updated by: Lingyun Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Phase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus Erythematosus

This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments. The underlying hypothesis is that the active SLE condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria:

  1. All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8;
  2. Lupus nephritis with 24h urine protein≥1g;

  3. Refractory disease as determined by failure of the following regimens:

    Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide 0.4 ~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months;

  4. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
  5. Willing to use contraception throughout the study and for 12 months following treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • The Affiliated Drum Tower Hospital of Nanjing University Medical School
        • Contact:
          • Sun
          • Phone Number: +86-25-83105209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 60 years old, SLEDAI≥8;
  • Lupus nephritis with 24h urine protein≥1g;
  • Refractory disease as determined by failure of the following regimens:

Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide 0.4 ~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months;

  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
  • Willing to use contraception throughout the study and for 12 months following treatment

Exclusion Criteria:

  • Abnormal liver function (ALT higher than 3 times the normal value);
  • End-stage renal failure;
  • Severe heart and pulmonary failure, or other important organs damage;
  • Uncontrolled infections
  • Pregnant or breast feeding women, male or female who intended to recent pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: human umbilical cord derived MSC
human umbilical cord derived MSC transplantation for SLE
Biological: human umbilical cord derived MSC transplantation for SLE
Other Names:
  • Allogenic MSC derived from umbilical cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
British Isles Lupus Assessment Group score (BILAG)
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Lupus serology (Alb, ANA, dsDNA, C3, C4)
Time Frame: pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation
pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation
Renal function (GFR, Blood Urea Nitrogen, urinalysis)
Time Frame: pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation (for GFR assessed at baseline and 12 months after MSCT)
pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation (for GFR assessed at baseline and 12 months after MSCT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Lingyun Sun, MD, PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJGLYY005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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