A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease

NCT ID: NCT03056742

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2019-10-31

Brief Summary

This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). 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).

Detailed Description

This study will evaluate the safety and efficacy of intramuscular injection of stempeucel(R) (Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells) in Critical Limb Ischemia due to Buerger's Disease

Conditions

Critical Limb Ischemia Due to Buerger's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cells

Patients will receive intramuscular and local injection of stempeucel(R) in addition to standard protocol of care

Group Type: EXPERIMENTAL

Stempeucel(R)

Intervention Type: BIOLOGICAL

Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells

Interventions

Stempeucel(R)

Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Buerger's disease as diagnosed by Shionoya criteria

2. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs.

3. Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5;

4. 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) .

5. 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) .

6. ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.

7. 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.

Exclusion Criteria

1. Patients with CLI indicated for major amputation during screening

2. Atherosclerotic PAD

3. Ulcers with exposure of tendon and/bone in the shin region.

4. Previous above trans metatarsal amputation in study limb

5. Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening

6. Patients with gait disturbance for reasons other than CLI

7. Diagnosis of diabetes mellitus (type 1 or type 2)

8. Patients having left ventricular ejection fraction < 35%

9. Patients suffering from clinically relevant peripheral neuropathy

10. History of stroke or myocardial infarction

11. Patients who are contraindicated for MRA

12. Patients with DVT in any limb.

13. 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

14. Documented terminal illness or cancer or any concomitant disease process with a life expectancy of <1 year

15. Patients already enrolled in another investigational drug trial or completed within 3 months or those who have received stem cells in the past

16. Patient with known hypersensitivity to the constituents of the stempeucel®- dimethyl sulfoxide (DMSO) or human serum albumin (HSA)

17. History of severe alcohol or drug abuse within 3 months of screening

18. Hb% < 10 gm% for males, Hb% < 9 gm% for females, serum creatinine ≥ 2mg%, serum Total Bilirubin ≥2mg%

19. Pregnant and lactating women

20. Patients tested positive for HIV 1 & 2, HCV, HBV, CMV, RPR antibodies and for HBsAg antigen

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stempeutics Research Pvt Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals

Bangalore, Karnataka, India

Department of Surgical Disciplines, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Department of Vascular Surgery, Madras Medical College

Chennai, Tamil Nadu, India

Department of Vascular Surgery, Sri Ramchandra Medical College

Chennai, Tamil Nadu, India

Saveetha Medical College & Hospital

Chennai, Tamil Nadu, India

SRM Medical College Hospital and Research Centre

Chennai, Tamil Nadu, India

Health Point Hospital

Kolkata, West Bengal, India

Nightingale Hospital

Kolkata, West Bengal, India

Countries

India

Other Identifiers

SRPL/CLI/10-11/001 Version 4

Identifier Type: -

Identifier Source: org_study_id