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Clinical Trials/CTRI/2015/04/005716
CTRI/2015/04/005716
Recruiting
Phase 1

A Pilot Study on the Efficacy of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Systemic Lupus Erythematosus

KIMS Foundation and Research Center and Krishna Institute of Medical Sciences0 sites10 target enrollmentTBD
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ConditionsHealth Condition 1: null- Systemic lupus erythematosus

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: null- Systemic lupus erythematosus
Sponsor
KIMS Foundation and Research Center and Krishna Institute of Medical Sciences
Enrollment
10
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
KIMS Foundation and Research Center and Krishna Institute of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • •1\. Treatment\-refractory and active disease
  • •2\. SLEDAI score of \> 8 with positive antinuclear antibodies
  • •3\. At least one BILAG grade A or two BILAG grade B manifestation
  • •4\. Major organ damage (cerebritis, nephritis, pulmonary, cardiac or skin vasculitis) despite optimal immunosuppression.
  • •5\. Adequate hemoglobin (\>\=8\.0g/dL) and other blood components
  • •6\. Adhere to study visit schedule and other protocol requirement
  • •7\. Able to give informed consent

Exclusion Criteria

  • •1\. Significant end organ damage
  • •2\. Any history of ongoing, significant or recurring infections.
  • •3\. Any active inflammatory diseases other than SLE.
  • •4\. Significant cardiac or pulmonary disease.
  • •5\. End\-stage renal failure.
  • •6\. Pregnant or lactating women
  • •7\. Malignancy
  • •8\. Not fit for anesthesia
  • •9\. Poor nutritional status
  • •10\. Patient who do not consent

Outcomes

Primary Outcomes

Not specified

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