CTRI/2015/04/005716招募中1 期
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 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
- •11. Patient on ventilatory support
- •12. Continued abuse of alcohol or other drugs
- •13. Hepatitis B , HIV or HCV positive subjects
- •14. Unable to give consent
- •15. Psychiatric disorder/mentally unstable
研究者
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