| CTRI Number |
CTRI/2025/06/088469 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post marketing surveillance of assess safety and efficacy of intramuscular administration of REGENACIP |
|
Scientific Title of Study
|
An observational, practice based, open label, multicenter, post marketing surveillance study in India to assess safety and efficacy of intramuscular administration of REGENACIP® in patients with Critical Limb Ischemia (CLI) due to Buerger’s disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRPL/CLI-BD/20-21/005 VERSION 1.0 DATE: 27/08/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pawan Kumar Gupta |
| Designation |
President – Medical & Regulatory Affairs |
| Affiliation |
Stempeutics Research Pvt Ltd |
| Address |
Stempeutics Research Pvt. Ltd., 3rd Floor, Manipal Hospitals Whitefield, ITPL Road, Whitefield, Bangalore - 560048
Bangalore
KARNATAKA
560048
India |
| Phone |
8025028103 |
| Fax |
|
| Email |
pawan.gupta@stempeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Kumar Gupta |
| Designation |
President – Medical & Regulatory Affairs |
| Affiliation |
Stempeutics Research Pvt Ltd |
| Address |
Stempeutics Research Pvt. Ltd., 3rd Floor, Manipal Hospitals Whitefield, ITPL Road, Whitefield, Bangalore - 560048
KARNATAKA
560048
India |
| Phone |
8025028103 |
| Fax |
|
| Email |
pawan.gupta@stempeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Jijy Abraham |
| Designation |
Deputy Manager (Regulatory Affairs) |
| Affiliation |
Stempeutics Research Pvt. Ltd |
| Address |
Stempeutics Research Pvt. Ltd., 3rd Floor, Manipal Hospitals Whitefield, ITPL Road, Whitefield, Bangalore - 560048
Bangalore
KARNATAKA
560048
India |
| Phone |
9900245795 |
| 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
ITPL Main Road
Bengaluru – 560 048
Cipla Limited
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400013, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Stempeutics Research Pvt. Ltd |
| Address |
3rd Floor, Manipal Hospitals Whitefield,
#143, 212-215, EPIP Industrial Area
ITPL Road, Whitefield,
Bangalore - 560048 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santanu Dutta |
LIFE LINE DIAGNOSTIC CENTER CUM NURSING HOME |
Clinical research Department, 2nd floor, room No. 201, 4A WOOD STREET KOLKATA Kolkata West Bengal 700016 India
Kolkata
WEST BENGAL |
9830808666
dr.santanudutta14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC LIFELINE DIAGNOSTIC CENTER CUM NURSING HOME |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I731||Thromboangiitis obliterans [Buergers disease], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Regenacip |
Single Intramuscular administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Written, signed, dated informed consent obtained from patients.
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 III) with rest pain and / or ulcers in the affected limb.
Patients who are not eligible for or have failed traditional revascularization treatment. |
|
| ExclusionCriteria |
| Details |
Patients with known hypersensitivity to the excipients of the REGENACIP® – dimethylsulfoxide (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 |
Safety Endpoint:
- Evaluation of adverse events
- Evaluation of drug related adverse events
- Evaluation of occurence of clinical abnormality at site of injection, calf area, vital signs and physical examinations |
1, 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy assessment will include:
- Rest pain score (VAS Scale score of 0 to 10) (refer appendix II) & or
- Ankle brachial pressure index (Ratio of ankle pressure to brachial pressure) & or
- Ulcer status (Ulcer Present (Yes/No). If present (healed/Improved/not healed at follow up) |
Assessment will be performed at 1, 6 and 12 Month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
24/06/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational, open label, multicenter, post marketing surveillance study in India to assess safety and efficacy of intramuscular administration of REGENACIP® in patients with Critical Limb Ischemia (CLI) due to Buerger’s disease. |