| CTRI Number |
CTRI/2018/06/014436 [Registered on: 06/06/2018] Trial Registered Prospectively |
| Last Modified On: |
27/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study of Stempeucel® in Patients with severe blockage in the blood vessels of the legs |
|
Scientific Title of Study
|
A Label Extension, Single Arm Multicentric Phase III Study to Assess the Efficacy and Safety of Stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Critical Limb Ischemia Due to Atherosclerotic Peripheral Arterial Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRPL/CLI/17-18/002, Version: 2.0, Date: 05 December 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pawan Kumar Gupta |
| Designation |
Vice President – Medical Affairs |
| Affiliation |
Stempeutics Research Pvt. Ltd. |
| Address |
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215,
EPIP Industrial Area, K R Puram Hobli
Bangalore
KARNATAKA
560048
India |
| Phone |
08025028101 |
| Fax |
|
| Email |
pawan.gupta@stempeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Kumar Gupta |
| Designation |
Vice President – Medical Affairs |
| Affiliation |
Stempeutics Research Pvt. Ltd. |
| Address |
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215,
EPIP Industrial Area, K R Puram Hobli
Bangalore
KARNATAKA
560048
India |
| Phone |
08025028101 |
| Fax |
|
| Email |
pawan.gupta@stempeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Jijy Abraham |
| Designation |
Senior Executive - Regulatory & Clinical Trials |
| Affiliation |
Stempeutics Research Pvt. Ltd. |
| Address |
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215,
EPIP Industrial Area, K R Puram Hobli
Bangalore
KARNATAKA
560048
India |
| Phone |
08025028112 |
| Fax |
|
| Email |
jijy.abraham@stempeutics.com |
|
|
Source of Monetary or Material Support
|
| Stempeutics Research Pvt. Ltd, 3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd. #143, 212-215, EPIP Industrial Area, K R Puram Hobli, Bengaluru – 560 048, phone: 08025028101 |
|
|
Primary Sponsor
|
| Name |
Stempeutics Research Pvt Ltd |
| Address |
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd. #143, 212-215, EPIP Industrial Area, K R Puram Hobli, Bengaluru – 560 048, phone: 08025028101 |
| Type of Sponsor |
Other [Research Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anita Dhar |
All India Institute of Medical Sciences |
Department of clinical research, Room No.NA, AIIMS, Ansari Nagar, Delhi-29
New Delhi
DELHI |
09810198239
dranitadharbhan@gmail.com |
| Dr Santanu Dutta |
Bellevue Clinic |
9,Department of clinicalresearch,dr. U.N.Bramachari Street, (formally Loundon Street-700017
Kolkata
WEST BENGAL |
9811047390
dr.santanudutta09@yahoo.com |
| Dr Vinay Krishna |
GSVM Hospital |
Department of clinical research, Room No.NA,Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH |
09415040271
vinaycvts11@rediffmail.com |
| Dr Shubendu sekhar Mahapatra |
Health Point Hospital |
Department of clinical research, Room No#21 pranath pandit street-700025
Kolkata
WEST BENGAL |
09433283336
apurasm@yahoo.co.in |
| Dr Vasanth Kumar Reddy |
Krishna Institute of medical science |
Department of clinical research, A-5/3, E Mazla Colony,secunderabad-500003
Hyderabad
ANDHRA PRADESH |
09908028855
surgeon.vasant@gmail.com |
| Dr Sanjay C Desai |
M S Ramaian Medical college & hospital |
Room No 8, Department of Vascular and Endovascular Surgery, M S Ramaiah Nagar,New BEL Road, MSRIT Post-560054
Bangalore
KARNATAKA |
09845290575
scdesai@hotmail.com |
| Dr Sritharan Narayanan |
Madras Medical College and Rajiv Gandhi Government General Hospital |
Department of clinical research, Room No.NA, E.V.R periyar Salai, Park Town-600003
Chennai
TAMIL NADU |
09840133158
sritharann@hotmali.com |
| Dr Rajiv parakh |
Medanta-the medicity |
Department of clinical research, Room No.NA, Sector-38-122001
Gurgaon
HARYANA |
09810577390
rajiv.parakh@medanta.org |
| Dr Muralikrishna N |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
Department of clinical research, Room No.NA, Bannerghatta Road, 9th Block, Jayanagar- 560069
Bangalore
KARNATAKA |
09880133066
drmurali1978@yahoo.co.in |
| Dr Radhakrishnan |
Sri Ramachandra Medical Centre |
Department of Vascular Surgery,
Sri Ramachandra Medical Centre,
No.l. Ramachandra Nagar,
Porur-600116.
Chennai
TAMIL NADU |
09840073083
rrkrishnan@hotmail.com |
| Dr M Rajkumar |
Vijaya Medical & educational trust |
Department of clinical research,No. 434(old No.180), N.S.K salai, vadapalani-600026
Chennai
TAMIL NADU |
09841025996
dr_rajkumar47@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Belle Vue Clinic, Institutional Ethics Committee,Dr. Santanu Dutta |
Submittted/Under Review |
| Ethics Committee, G.S.V.M Medical College, Dr. Vinay Krishna |
Approved |
| Ethics Committee, M S Ramaian Medical college & hospital,Dr. Sanjay .C .Desai |
Approved |
| Health Point Ethics Committee, Dr. Subhendu |
Approved |
| Institutional Ethics committee AIIMS,Dr Anita |
Approved |
| Institutional Ethics committee sri ramachandra institute of higher education and research,Dr. Radhakrishnan |
Approved |
| Institutional Ethics committee the madras medical mission,Dr. Sritharan Narayanan |
Approved |
| Institutional Ethics Committee, Vijaya Institute of Clinical and Medical Research, Dr. M Rajkumar |
Approved |
| KIMS Ethics Committee,Dr. Vasanth Kumar |
Approved |
| Medanta Institutional Ethics committee, dr rajiv parakh |
Approved |
| Sri Jayadeva Institute Ethics Committee,Dr. Muralikrishna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M622||Nontraumatic ischemic infarction of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Stempeucel® |
Stempeucel® consists of ex
vivo cultured adult bone marrow derived allogeneic
Mesenchymal Stromal Cells.
Stempeucel® will be injected at a dose of 2 million cells/kg body weight intramuscularly once during the trial. Additionally, 8 million cells will also be injected around the ulcer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Males or females with non-child bearing potential in the age group of 18-70 years of Indian origin.
2. Established CLI, clinically and hemodynamically confirmed as per III-5, or III-6; Patients in Rutherford- III-6 if gangrene extending maximally up to the head of metatarsal but limited to toes (Patients with wet gangrene must undergo wound debridement / amputation before screening).
3. Patients having Infra-inguinal arterial occlusive disease (as evidenced by MRA) with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
4. Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm square (both inclusive)
5. Ankle Brachial Pressure Index (ABPI) less than or equal to 0.6
6. Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c less than or equal to 8 percentage) without complications
7. Normal liver and renal function
8. On regular medication for hypertension if any
9. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent including audio – video consent, abide by the study requirements, and agree to return for required follow-up visits |
|
| ExclusionCriteria |
| Details |
1. Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure
2. Buerger’s Disease as diagnosed by Shionoya criteria
3. Patients with rest pain VAS score less than 3 on rest pain scale of 0 – 10 (0 is no pain; 10 is maximum pain)
4. Ulcers with exposure of tendon and/bone in the shin region.
5. Severe, active infection of the involved extremity, including osteomyelitis, fasciitis, or severe/purulent cellulitis.
6. CLI patient requiring amputation proximal to trans-metatarsal level
7. Patients with gait disturbance for reasons other than CLI.
8. Type I diabetes
9. Patients having respiratory complications/left ventricular ejection fraction less than 35%
10. Stroke or myocardial infarction within last 3 months
11. Patients with deep vein thrombosis in any limb
12. Patients who are contraindicated for MRA
13. Have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
14. Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year
15. Patients already enrolled in another investigational drug trial or completed within 3 months.
16. Patients who have participated in any stem cell trial / therapy / gene therapy any time in the past
17. History of severe alcohol or drug abuse within 3 months of screening.
18. Hb percentage less than 10 gm percentage for males, Hb percentage less than 9 gm percentage for females, serum creatinine greater than or equal to 2 mg percentage, serum Total Bilirubin greater than or equal to 2 mg percentage
19. Women with child bearing potential, pregnant and lactating women.
20. Patient with known hypersensitivity to the constituents of the IMP– DMSO
21. Patients tested positive for HIV (1 or 2), HCV, HBV, CMV, TPHA
22. Subject is an employee or relative of any member of the Investigational site or the Sponsor.
23. Refusal or inability to give informed consent including audio-video consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the efficacy of stempeucel® |
1,3,6,12 months after IMP administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of the safety of stempeucel® |
Day 7, 1,3,6,12 months after IMP administration |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3 |
|
Date of First Enrollment (India)
|
11/06/2018 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a label extension, single arm, multicentric phase III study to assess the efficacy and safety of stempeucel® (adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells) in patients with critical limb ischemia due to atherosclerotic peripheral arterial disease. A total of 24 patients will be enrolled into the study at study centres across India. All patients will be followed up for 1 year after they are enrolled into the study. This is an open label, single arm study group where all the patients will receive stempeucel® (2 million cells per Kg body weight) administered intramuscularly at 40-60 multiple sites to the ischemic limb and also 2 - 3 ml around the ulcer along with standard protocol of care. This study will be conducted to further evaluate the efficacy and safety of the product. The study will be conducted as a clinical trial in accordance to “Guidelines for Stem Cell Research and Therapy” by Department of Biotechnology and ICMR, 2017, the EMA guidelines on human cell based medicinal products, 2007, Schedule-Y and International Council for Harmonisation (ICH) Good Clinical Practices (GCP) and as per the recommendations of the CBBTDEC; approvals will be taken from relevant ethics committees and approval / NOC from DCGI before starting the study. |