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

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ClinicalTrials.gov Identifier: NCT01741857
Recruitment Status : Unknown
Verified October 2012 by Lingyun Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
First Posted : December 5, 2012
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Lingyun Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: human umbilical cord derived MSC transplantation for SLE Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus Erythematosus
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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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 Name: Allogenic MSC derived from umbilical cord


Outcome Measures
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Primary Outcome Measures :
  1. British Isles Lupus Assessment Group score (BILAG) [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Lupus serology (Alb, ANA, dsDNA, C3, C4) [ Time Frame: pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation ]
  2. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741857


Locations
China, Jiangsu
The Affiliated Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Sun    +86-25-83105209      
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
Principal Investigator: Lingyun Sun, MD, PhD the Affiliated Drum Tower Hospital of Nanjing University Medical School
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lingyun Sun, Department of Rheumatology and Immunology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT01741857     History of Changes
Other Study ID Numbers: NJGLYY005
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: October 2012

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases