A study to evaluate the safety and efficacy of R-HSC-010 (stem cells) in patients with chronic kidney disease

Phase 1

• Conditions: Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)

• Registration Number: CTRI/2020/02/023109
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 �30 mg/g (�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 <2 times upper limit of normal (ULN)

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events occurring during the studyTimepoint: Day 0, 1 Month, 3 Month, 6 Month, 9 month and 12 Month

Secondary Outcome Measures

Name	Time	Method
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