Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
Conditions
Interventions
Intervention1: Stem Cells: Umbilical Cord Derived Mesenchymal Stell Cells (R-HSC-010) at a signle dose of 2 million cells/kg or 4 million cells/kg of body weight at Day 0
Control Intervention1: NIL: N
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must be able to give voluntary written informed consent 2. Age 18 to 65 years 3. BMI between 18-30 kg/m2 4. Patients with stage III chronic kidney disease 5. Subjects with moderate to severe albuminuria ââ?°Â¥30 mg/g (ââ?°Â¥3 mg/mmol) 6. Proteinuria >1 gm/day 7. Subjects should have LVEF > 45% as confirmed by 2D ââ?¬â??ECHO 8. Patient should be afebrile 24 hours prior to procedure 9. Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin 10. Females of childbearing potential must have negative serum pregnancy test at screening and agree to use adequate contraception throughout the study period
Exclusion criteria
Exclusion criteria: 1. Patients with Acute Renal Failure 2. Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores or any other condition which will contraindicate the use of study treatment or procedures 3. Chronic kidney disease due to autoimmune etiology, connective tissue disease, amyloidosis and storage disorders 4. Haemoglobin less than 9 gm/dl 5. Uncontrolled Diabetes mellitus with HbA1C � 8.0% 6. Patients with HIV, HBsAg and HCV test positive 7. Known bleeding or coagulation disorder 8. Known hematologic disease 9. Evidence of active malignancy within one year prior to IP administration 10. Severe skin infection or osteomyelitis 11. Pregnant or breast feeding, or planning to become pregnant during study period 12. Patients on immunosuppressive therapy 13. History of drug or alcohol abuse 14. Presence of ongoing local or systemic infection 15. Subjects judged by the investigator to be at significant risk of failing to comply with the requirements of the protocol 16. Treatment with an investigational product within 1 year prior to trial entry 17. Uncontrolled hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure > 90 mmHg) 18. Participation in any other clinical trial over the past 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events occurring during the studyTimepoint: Day 0, 1 Month, 3 Month, 6 Month, 9 month and 12 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in chronic kidney disease stage (from stage III to II or I) as per KDIGO guidelines at all post-therapy study visitsTimepoint: Day 0, 1 Month, 3 Month, 6 Month, 9 month and 12 Month | — |
Countries
India
Contacts
Public ContactSachin Singh
Reliance Life Sciences Pvt. Ltd
Outcome results
None listed