Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis (hUC-MSC-SLE)

March 5, 2012 updated by: CytoMed & Beike

A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis

The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria:

  1. Male or non-pregnant females age 16 to 65 years inclusive.
  2. Written informed consent obtained from patient or parents/guardian.
  3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
  4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

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
    • Yunan
      • Kunming, Yunan, China, 650000
        • Recruiting
        • Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China
        • Contact:
        • Principal Investigator:
          • DanQi Deng, Professor
        • Sub-Investigator:
          • PeiLian Zhang, Dr

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

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or non-pregnant females age 16 to 65 years inclusive.
  2. Written informed consent obtained from patient or parents/guardian.
  3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
  4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis

Exclusion Criteria:

Patients with any of the following are not eligible for enrollment into the study:

  1. Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
  2. Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
  3. Those persons directly involved in the conduct of the study.
  4. Serum creatinine more than 250 µmol/L.
  5. White blood cell (WBC) count of less than 3.5 X 109/L.
  6. Active peptic ulcer disease.
  7. Active systemic infection.
  8. History of alcohol or substance abuse.
  9. History of malignancy within previous 5 years.
  10. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Human Umbilical Cord derived MSCs
Biological: Human Umbilical Cord derived MSCs
Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion
Other Names:
  • Allogeneic stem cells derived from umbilical cord
Placebo Comparator: Cyclophosphamide
Drug: Cyclophosphamide
Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
Other Names:
  • Immunosupressive agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy and Safety
Time Frame: 6 months

The efficacy measure is remission of nephritis (combined partial and complete remission) at 6 months defined as

  • Stabilization or improvement in renal function and
  • Urinary RBC of less than 10 per HPF and
  • Reduction of proteinuria to less than 3 g/day if baseline proteinuria was more than 3 g/day and at least a 50% reduction in proteinuria, or to less than 1 g/day if the baseline proteinuria was in the subnephrotic range.
6 months

Collaborators and Investigators

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

Sponsor

CytoMed & Beike

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

February 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

March 6, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT 11-03

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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