Autologous Mesenchymal Stem Cell Therapy in Lupus

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/04/005716

Enrollment

Registered

2015-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Systemic lupus erythematosus

Interventions

Intervention1: Mesenchymal Stem Cell Therapy: Intravenous injection of 1 million autologous mesenchymal stem cells per kg body weight at day O, 30 and 60 Control Intervention1: NIL: NIL

Eligibility

Inclusion 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

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactDr Kanaka Bhushanam

Krisha Institute of Medical Sciences KIMS Foundation and Research Centre

syedsbeevi@kfrc.co.in914044885078

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026