Autologous Mesenchymal Stem Cell Therapy in Lupus

Phase 1

• Conditions: Health Condition 1: null- Systemic lupus erythematosus

• Registration Number: CTRI/2015/04/005716
• Lead Sponsor: KIMS Foundation and Research Center and Krishna Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in SLE Disease activity index score (Time Frame 6 months) <br/ ><br>2. British Isles Lupus Assessment Group (BILAG) score (Time Frame 6 months) <br/ ><br>3. Change in Quality of Life Assessment Questionnaire (Time Frame 6 months) <br/ ><br>4. Change in standardized clinical & laboratory criteria(Time Frame 6 months) <br/ ><br>5. Number of adverse events as a measure of safety (Time Frame 1, 3 months) <br/ ><br>Timepoint: 1, 3 ,6 Months

Secondary Outcome Measures

Name	Time	Method
1. Change in SLE Disease activity index score (Time Frame 6 months) <br/ ><br>2. British Isles Lupus Assessment Group (BILAG) score (Time Frame 6 months) <br/ ><br>3. Change in Quality of Life Assessment Questionnaire (Time Frame 6 months) <br/ ><br>4. Change in standardized clinical & laboratory criteria(Time Frame 6 months) <br/ ><br>5. Number of adverse events as a measure of safety (Time Frame 1, 3 months) <br/ ><br>Timepoint: 1, 3 ,6 Months