| CTRI Number |
CTRI/2018/02/011839 [Registered on: 12/02/2018] Trial Registered Prospectively |
| Last Modified On: |
16/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Stem Cell Therapy |
| Study Design |
Other |
|
Public Title of Study
|
A study of stempeucel® in patients with critical limb ischemia due to occlusive inflammatory condition of arteries and veins |
|
Scientific Title of Study
|
An open label, multicenter Post Marketing Surveillance Study in India to assess safety and efficacy of Intramuscular administration of stempeucel® in patients with critical limb ischemia due to Buerger’s disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 0486-17, Version: 03, Date: 05/12/2017 |
Other |
|
|
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
Modification(s)
|
| 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. K R Puram Hobli, Bengaluru – 560 066
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 – 560 066
Phone – 08025028101
|
| Type of Sponsor |
Other [Research & Development Institution] |
|
|
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 Arunanshu Bahera |
Nehru Hospital |
Department of Surgery,Room no. NA PGIMER, Sector 12-160012
Chandigarh
CHANDIGARH |
07087009638
abe190859@yahoo.com |
| Dr Anita Dhar |
All India Institute of Medical Sciences |
Dept of clinical research,Room-5075, 5th Floor, Teaching Block, Ansari Nagar
New Delhi
DELHI |
09810198239
dranitadharbhan@gmail.com |
| Dr Santanu Dutta |
Bellevue Clinic |
9, Dept of clinical research, Room no. NA, Dr. U.N. Brahmachari Street. (Formerly Loundon Street)-700017 -700017
Kolkata
WEST BENGAL |
9830808666
dr.santanudutta09@yahoo.com |
| Dr Sanjay Kala |
GSVM medical college |
Department of Surgery, Room no. NA, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH |
9839210014
surgerygsvmmc@gmail.com |
| Dr Subhendu S Mahapatra |
Health point Hospital |
Room No: 13, Dept of clinical research, 21 Prannath Pandit Street (Opposite Lansdown Padmapukur)-700025
Kolkata
WEST BENGAL |
9433283336
apurasam@yahoo.co.in |
| Dr Narendranath Meda |
Krishna Institute of Medical Science |
1-8-31/1, Minister Road, Krishna Nagar Colony, Begumpet, Secunderabad, 500003, Telangana
Hyderabad
ANDHRA PRADESH |
9704084841
narendrameda@gmail.com |
| Dr Sanjay C Desai |
M S Ramaiah Medical College and Hospitals |
Room No 8, Department of Vascular and Endovascular Surgery, M.S Ramaiah Nagar, MSRIT Post-560054
Bangalore
KARNATAKA |
9845290575
scdesai@hotmail.com |
| DrMuralikrishna Nekkanti |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
Dept of clinical research,Jayanagara 9th Block, Bannerghatta Main Road
Bangalore
KARNATAKA |
09880133066
drmurali1978@yahoo.co.in |
| Dr Radhakrishnan R |
Sri Ramachandra Medical center |
2nd Floor, C2 of the Medical Centre building, Dept of clinical research, Room no. NA, Sri Ramachandra Hospital, No.l, Ramachandra Nagar, Porur- 600116
Chennai
TAMIL NADU |
9840073083
srmclinicalresearch@gmail.com |
| Dr R Balamurugan |
SRM Medical College Hospital & Research Centre |
SRM Nagar, Potheri, Kattankulathur- 603203
Kancheepuram
TAMIL NADU |
9841434506
dr.bala.ms@gmail.com |
| Dr M Rajkumar |
Vijaya Hospital |
Vijaya hospital & Enducational trust, No 434, N.S.K. Salai, Vadapalani-600026
Chennai
TAMIL NADU |
9841025996
dr_rajkumar47@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee M S Ramaiah Medical College and Hospitals |
Approved |
| Ethics Committee, G.S.V.M Medical College |
Approved |
| Health Point Ethics Committee |
Approved |
| Institute Ethics committee All India Institute of Medical sciences, Dr Anita |
Approved |
| Institutional Ethics Committee, Bellevue Clinic |
Approved |
| Institutional Ethics committee, Post Graduate Institute of Medical Education and Research,Dr. Arunanshu Bahera |
Approved |
| Institutional Ethics Committee, Sri Ramachandra Medical College and Research Institute |
Approved |
| Institutional Ethics Committee, SRM Medical College hospital |
Approved |
| Institutional Ethics Committee, Vijaya Institute of Clinical and Medical Research |
Approved |
| KIMS Ethics Committee |
Approved |
| Sri Jayadeva Institute Ethics Committee,Dr. Muralikrishna |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
| Status |
| No Objection Certificate |
|
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 stem cells.
Stempeucel® will be
injected at a dose of 2 million cells/kg body weight intramuscularly once during the trial. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Written, signed, dated and ethics committee approved informed consent obtained from patients before performing any procedures.
2. Patients of either sex of 18 years and above with established clinical diagnosis of critical limb ischemia due to Buerger’s disease as per Rutherford classification (Rutherford III-5 or III-6 (gangrene limited to the toes)) (Refer Appendix I) with rest pain and / or ulcers in the affected limb.
3. Patients who are not eligible for or have failed traditional revascularization treatment
|
|
| ExclusionCriteria |
| Details |
Patients with known hypersensitivity to the excipients of the stempeucel® – dimethyl sulfoxide (DMSO) or human serum albumin (HSA) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Safety, tolerability and Efficacy |
1, 6 and 12, 24, 36 and 48 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
27/03/2018 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Buerger’s disease (Thromboangiitis obliterans (TAO)) is a serious medical condition with an unmet medical need. The disease is characterized by segmental occlusive inflammatory condition of arteries and veins, and thrombosis and recanalization of the affected vessels. Buerger’s disease usually occurs in people around the age of 40 - 45 years and is more frequent in male smokers. Critical limb ischaemia (CLI) due to Buerger’s disease is a manifestation of peripheral arterial disease (PAD) that describes patients with chronic ischaemic rest pain, or patients with ischaemic skin lesions, either ulcers or gangrene. Stempeucel® is a formulation of Adult human bone marrow derived, cultured, pooled allogeneic Mesenchymal Stromal Cells (MSCs) intended for intramuscular injection (IM) only. Stempeucel® is indicated in Buerger’s disease patients with established critical limb ischemia in Rutherford III-5 or III-6 (gangrene limited to the toes), not eligible for or have failed traditional revascularization treatment, with rest pain and / or ulcers in the affected limb. This post marketing surveillance study will include 200 patients administered with stempeucel® in 10 selected centres. These patients will be followed up for a duration of 12 months from the time of administration of stempeucel®. This PMS study is being conducted post marketing approval of the product Stempeucel® for CLI due to Buerger’s disease as per the regulatory requirement.
|