| CTRI Number |
CTRI/2020/02/023109 [Registered on: 04/02/2020] Trial Registered Prospectively |
| Last Modified On: |
25/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate the safety and efficacy of R-HSC-010 (stem cells) in patients with chronic kidney disease |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RLS/RM/HSC/2012/06 Version 5 dated 7 Sep 2018 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ajaykumar Yadav |
| Designation |
Principal Investigator |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. (RLS) |
| Address |
Reliance Life Sciences Pvt. Ltd,Dhirubhai Ambani Life Sciences Centre, Plot-R-282, TTC Area of MIDC,Thane-Belapur Road, Rabale,Navi Mumbai 400701, Maharashtra, India
Thane
MAHARASHTRA
400701
India |
| Phone |
9820804218 |
| Fax |
|
| Email |
Ajaykumar2.Yadav@relbio.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Supriya Sonowal |
| Designation |
Medical Monitor |
| Affiliation |
Reliance Life Sciences Pvt. Ltd |
| Address |
Reliance Life Sciences Pvt. Ltd,Dhirubhai Ambani Life Sciences Centre, Plot-R-282,
TTC ARea of MIDC,Thane-Belapur Road, Rabale,Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
9427003728 |
| Fax |
|
| Email |
supriya.sonowal@relbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachin Singh |
| Designation |
Head-Clinical Operations |
| Affiliation |
Reliance Life Sciences Pvt. Ltd |
| Address |
Reliance Life Sciences Pvt. Ltd,Dhirubhai Ambani Life Sciences Centre, Plot-R-282,
TTC ARea of MIDC,Thane-Belapur Road, Rabale,Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
9004246165 |
| Fax |
|
| Email |
Sachin2.Singh@relbio.com |
|
|
Source of Monetary or Material Support
|
| Reliance Life Sciences Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Reliance Life Sciences Pvt Ltd |
| Address |
Reliance Life Sciences Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Rabale, Mumbai 400 701 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Jhorawat |
SMS Medical College and Hospital |
Department of Nephrology, Room No. 17, First Floor, Dhanvantri OPD Block, Jaipur 302004, Rajasthan, India
Jaipur
RAJASTHAN |
9461626614
jhorawat2000@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and Attached Hospitals, JLN Marg, Jaipur 302004, Rajasthan,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 –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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse events occurring during the study |
Day 0, 1 Month, 3 Month, 6 Month, 9 month and 12 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
01/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |