| CTRI Number |
CTRI/2010/091/000565 [Registered on: 24/11/2010] |
| Last Modified On: |
09/09/2014 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Stem Cell Therapy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to evaluate the effect of bone marrow derived stem cell in diseases Limb Ischemia |
Scientific Title of Study
Modification(s)
|
Induction of therapeutic Angiogenesis in Limb Ischemia by Intra-arterial delivery of Autologous bone marrow derived stem cells |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sanjiv Sharma |
| Designation |
Professor & Head |
| Affiliation |
|
| Address |
Dept.of Cardiac Radiology
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26594759 |
| Fax |
26588641 |
| Email |
meetisv@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanjiv Sharma |
| Designation |
Professor & Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept.of Cardiac Radiology
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26594759 |
| Fax |
011-26588641 |
| Email |
meetisv@yahoo.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sanjiv Sharma |
| Designation |
Professor & Head |
| Affiliation |
|
| Address |
Dept.of Cardiac Radiology
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26594759 |
| Fax |
011-26588641 |
| Email |
meetisv@yahoo.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Department of Biotechnology, New Delhi India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Department of Biotechnology New Delhi |
| Address |
Government of India
Ministry of Science & Technology
block-2 7th floor CGO complex
Lodhi Road, New Delhi 110003 |
| Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjiv Sharma |
All India Institute of Medical Sciences |
Dept. of Cardiac Radiology,All India Institute of Medical Sciences, Ansari Nagar-110029
New Delhi
DELHI |
01126594759
0112688641
meetisv@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Limb Ischemia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Treatment |
|
| Intervention |
stem cell Therapy |
40- 50 million cells |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Clinical
a)Rest pain requiring analgesia for > 2 weeks, and/or non healing ischemic ulcers
b)Absent /weak peripheral pulses
c)No response to smoking cessation for at least 3 months prior to evaluation
d)Not suited for surgical/ endovascular revascularization
d)Unilateral or bilateral involvement
e) Claudication distance of <200 meters.
2) Hemodynamic
a) Doppler study showing an occluded superficial femoral, popliteal, or infra-popliteal artery, with no or poor distal flow as evidenced by a monophasic, low velocity, collateralized flow pattern.
b) Contrast-enhanced magnetic resonance and digital subtraction angiography demonstrating the site of occlusion, status of distal run-off and the extent of collateralization
c) Ankle systolic pressure < 50 mm Hg
d) A resting ankle brachial pressure index <0.5 in the affected limb on 2 consecutive examinations done at least 2 days apart (normal range, 0.9-1.1).
|
|
| ExclusionCriteria |
| Details |
a)Poorly controlled diabetes mellitus
b)Evidence of a malignancy during the last 5 year
c)Renal dysfunction or other contraindication to injection of contrast media
d)Continued smoking
e)Limitation to exercise due to any reason other than claudication
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Changes in the composite of clinical status and improvement in TcO2 and improvement in ABI |
1, 3 and 6 month |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in the grade of collaterals or Improvement in the visualization of distal run-off vessels |
1, 3 and 6 month |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
15/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/01/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is randomised controlled clinical trial to evaluate the feasibility, safety and therapeutic efficacy of angiogenesis induced by intra-arterial delivery of stem cells derived from autologous bone marrow in patients with critical limb ischemia. |