| CTRI Number |
CTRI/2017/02/007836 [Registered on: 13/02/2017] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| 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 to evaluate efficacy and safety of stem cells in a condition involving severe obstruction of blood vessels of leg, particularly in smokers |
|
Scientific Title of Study
|
A single arm, open label, multicentric, clinical study assessing the efficacy and safety of intramuscular administration of stempeucel® (ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells) in patients with critical limb ischemia due to Buerger’s Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRPL/CLI/10-11/001, Version 4.0 dated 03/08/2016 |
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 |
Stempeutics Research Pvt Ltd Akshay Tech Park, No. 72 & 73, 2nd Floor, EPIP Zone, Phase I-Area Whitefield, Bangalore - 560066 India
Bangalore
KARNATAKA
560066
India |
| Phone |
91-80-39992405 |
| Fax |
91-80-39992402 |
| Email |
pawan.gupta@stempeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anoop CH |
| Designation |
Senior Manager - Clinical Research |
| Affiliation |
Stempeutics Research Pvt. Ltd. |
| Address |
Stempeutics Research Pvt Ltd Akshay Tech Park, No. 72 & 73, 2nd Floor, EPIP Zone, Phase I-Area Whitefield, Bangalore - 560066 India
Bangalore
KARNATAKA
560066
India |
| Phone |
91-80-39992430 |
| Fax |
91-80-39992402 |
| Email |
anoop.ch@stempeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Jijy Abraham |
| Designation |
Senior Executive - Regulatory & Clinical Trials |
| Affiliation |
Stempeutics Research Pvt. Ltd. |
| Address |
Stempeutics Research Pvt Ltd Akshay Tech Park, No. 72 & 73, 2nd Floor, EPIP Zone, Phase I-Area Whitefield, Bangalore - 560066 India
Bangalore
KARNATAKA
560066
India |
| Phone |
91-80-39992412 |
| Fax |
91-80-39992402 |
| Email |
jijy.abraham@stempeutics.com |
|
|
Source of Monetary or Material Support
|
| Stempeutics Research Pvt Ltd,
Akshay Tech Park,
No. 72 & 73, 2nd Floor,
EPIP Zone, Phase I-Area
Whitefield, Bangalore - 560066
India
|
|
|
Primary Sponsor
|
| Name |
Stempeutics Research Pvt Ltd |
| Address |
Stempeutics Research Pvt Ltd Akshay Tech Park, No. 72 & 73, 2nd Floor, EPIP Zone, Phase I-Area Whitefield, Bangalore - 560066 India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ecron Acunova |
Mobius Towers, SJR i-Park,
EPIP, Whitefield, Bangalore - 560066 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anita Dhar |
All India Institute of Medical Sciences |
Department of Surgical Disciplines, Main Building, All India Institute of Medical Sciences, Ansari Nagar - 110 029
New Delhi
DELHI
New Delhi
DELHI |
91-11-26588500
91-11-26588663
dranitadharbhan@gmail.com |
| Dr Subhendu Sekhar Mahapatra |
Health Point Hospital |
21 Prannath Pandit Street Opp. Lansdowne Padmapukur
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
91-33-30575700
91-33-24559037
apurasam@yahoo.co.in |
| Dr Sanjay C Desai |
M.S. Ramaiah Medical College and Hospitals |
Room No 8, Department of Vascular and Endovascular Surgery, M S Ramaiah Medical College and Hospitals, New BEL Road, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA |
080-23608888
080-40528402
scdesai@hotmail.com |
| Dr Jeyakumar S |
Madras Medical College |
Institute of Vascular Surgery, Madras Medical College E.V.R. Periar Salai, Park Town - 600 003
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
91-44-25305000
91-44-25305000
drjeyakumar.s@gmail.com |
| Dr Santanu Dutta |
Nightingale Hospital |
Nightingale Hospital, Polyclinic, 11, Shakespear Sarani - 700 071
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
91-33-22827462
91-33-22825377
dr.santanudutta09@yahoo.co.in |
| Dr Subramanian S R |
Saveetha Medical College & Hospital |
Dept of Vascular Surgery
2nd Floor Hospital Block
OPD no: 206
Prof & HOD room no: 215
Saveetha Medical College And Hospital
Saveetha Nagar, Thandalam,
Chennai- 602105
Tamilnadu
Chennai
TAMIL NADU |
044-66726632
044-66726623
profsrs3@hotmail.com |
| Dr Radhakrishnan R |
Sri Ramachandra Medical College and Hospital |
2nd Floor,
C2 of the Medical Centre building,
Sri Ramachandra Hospital,
No.l, Ramachandra Nagar, Porur, Chennai - 600116.
Tamil Nadu. India.
Chennai
TAMIL NADU |
044-45928699
044-24767008
rrkrishnan@hotmail.com |
| Dr M Rajkumar |
SRM Medical College Hospital and Research Centre |
OPD – Room No. 241, 2nd Floor,
Vascular department,
SRM Medical College Hospital & Research Center
Kattankulathur
Kancheepuram,603203,Chennai Tamil Nadu
Chennai
TAMIL NADU |
044-27455748
044-27455826
dr_rajkumar47@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences |
Submittted/Under Review |
| Ethics Committee, SRM Medical College Hospital & Research |
Approved |
| Health Point Ethics Committee |
Submittted/Under Review |
| Institutional Ehtics Committee Saveetha Medical College and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Madras Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, Sri Ramachandra University |
Submittted/Under Review |
| M.S. Ramaiah Medical College and hospitals ethics committee |
Approved |
| Nightingale ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I731||Thromboangiitis obliterans [Buergers disease], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| 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 |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Buerger’s disease as diagnosed by Shionoya criteria
b. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs.
c. Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5;
d. 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).
e. Patients having infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis (patients should have at least one measureable ulcer), who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients).
f. ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.
g. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent and video consent, abide by the study requirements, and agree to return for required follow-up visits. |
|
| ExclusionCriteria |
| Details |
a. Patients with CLI indicated for major amputation during screening
b. Atherosclerotic PAD
c. Ulcers with exposure of tendon and/bone in the shin region.
d. Previous above trans metatarsal amputation in study limb
e. Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
f. Patients with gait disturbance for reasons other than CLI
g. Diagnosis of diabetes mellitus (type 1 or type 2)
h. Patients having left ventricular ejection fraction < 35%
i. Patients suffering from clinically relevant peripheral neuropathy
j. History of stroke or myocardial infarction
k. Patients who are contraindicated for MRA
l. Patients with DVT in any limb.
m. Patients who 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
n. Documented terminal illness or cancer or any concomitant disease process with a life expectancy of <1 year
o. Patients already enrolled in another investigational drug trial or completed within 3 months or those who have received stem cells in the past
p. Patient with known hypersensitivity to the constituents of the stempeucel®– dimethyl sulfoxide (DMSO) or human serum albumin (HSA)
q. History of severe alcohol or drug abuse within 3 months of screening
r. Hb% < 10 gm% for males, Hb% < 9 gm% for females, serum creatinine ≥ 2mg%, serum Total Bilirubin ≥2mg%
s. Pregnant and lactating women
t. Patients tested positive for HIV 1 & 2, HCV, HBV, CMV, RPR antibodies and for HBsAg antigen |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Relief of the rest pain
• Healing of ulcerations or reduction of ulcer area in the target limb
|
6 months and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Total walking distance
• Major amputation free survival
• Ankle brachial pressure index (ABPI) – measured by Doppler
• Quality of life (QOL) by Kings College VascuQOL questionnaire
• Angiogenesis – collateral blood vessels by Magnetic resonance angiogram (MRA) |
6 months and 24 months |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2017 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (CTRI/2011/11/002107). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of Cellular biology based therapeutic drug evaluation committee (CBBTDEC). |