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

Phase 1

Not yet recruiting

• Conditions: Chronic kidney disease, stage 3 (moderate),

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

Brief Summary

This is a prospective, open label, two arm, phase I clinical study to evaluate the safety and efficacy of R-HSC-010 in patients with chronic kidney disease. The primary purpose of this study is to check if the UCMSC (Stem Cells) are effective and Safe at given doses in patients with CKD. Study hypothesis is that stem cells will decrease the severity of CKD from stage III to stage II or Stage I.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-07
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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 –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

• 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.
• 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 study	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 visits	Day 0, 1 Month, 3 Month, 6 Month, 9 month and 12 Month

Trial Locations

Locations (1)

SMS Medical College and Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

SMS Medical College and Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Rajesh Jhorawat

Principal investigator

9461626614

jhorawat2000@gmail.com