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

NCT03056742 | Withdrawn Phase 2 DMC

• 1 other identifier: SRPL/CLI/10-11/001 Version 4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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).

Conditions

Critical Limb Ischemia Due to Buerger's Disease

Outcome Measures

Primary Outcomes (2)

• Relief of the rest pain

  6 months

• Reduction of ulcer area in the target limb

  6 months

Secondary Outcomes (5)

• Total walking distance

  6 months and 24 months

• Major amputation free survival

  6 months and 24 months

• Ankle brachial pressure index (ABPI) - measured by Doppler

  6 months and 24 months

• Quality of life (QOL) by King's College VascuQOL questionnaire

  6 months and 24 months

• Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)

  6 months and 24 months

Other Outcomes (3)

• The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).

  6 months and 24 months

• CVS mortality

  6 months and 24 months

• All-cause mortality

  6 months and 24 months

Study Arms (1)

Stem cells

EXPERIMENTAL

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

Biological: Stempeucel(R)

Interventions

Stempeucel(R) BIOLOGICAL

Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells

Stem cells

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Buerger's disease as diagnosed by Shionoya criteria
• Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs.
• Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5;
• 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) .
• 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) .
• ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.
• 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.

You may not qualify if:

• Patients with CLI indicated for major amputation during screening
• Atherosclerotic PAD
• Ulcers with exposure of tendon and/bone in the shin region.
• Previous above trans metatarsal amputation in study limb
• Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
• Patients with gait disturbance for reasons other than CLI
• Diagnosis of diabetes mellitus (type 1 or type 2)
• Patients having left ventricular ejection fraction \< 35%
• Patients suffering from clinically relevant peripheral neuropathy
• History of stroke or myocardial infarction
• Patients who are contraindicated for MRA
• Patients with DVT in any limb.
• 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
• Documented terminal illness or cancer or any concomitant disease process with a life expectancy of \<1 year
• Patients already enrolled in another investigational drug trial or completed within 3 months or those who have received stem cells in the past

Sponsors & Collaborators

• Stempeutics Research Pvt Ltd: lead

Study Sites (8)

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

Bangalore, Karnataka, 560066, India

Location

Department of Surgical Disciplines, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Department of Vascular Surgery, Madras Medical College

Chennai, Tamil Nadu, 600003, India

Location

Department of Vascular Surgery, Sri Ramchandra Medical College

Chennai, Tamil Nadu, 600116, India

Location

Saveetha Medical College & Hospital

Chennai, Tamil Nadu, 602105, India

Location

SRM Medical College Hospital and Research Centre

Chennai, Tamil Nadu, 603203, India

Location

Health Point Hospital

Kolkata, West Bengal, 700025, India

Location

Nightingale Hospital

Kolkata, West Bengal, 700071, India

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 17, 2017
• Study Start: February 20, 2017
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2019
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (8)