NCT01484574

Brief Summary

This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

November 27, 2011

Last Update Submit

September 12, 2016

Conditions

Critical Limb IschemiaBuerger's Disease

Keywords

Critical limb ischemiaBuerger's diseaseCritical limb ischemia due to Buerger's disease

Outcome Measures

Primary Outcomes (4)

  • Relief of the rest pain

    Rest pain will be measured using rest pain scale (0 to10)

    6 months

  • Healing of ulcerations or reduction of ulcer area in the target limb

    Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.

    6 months

  • Relief of the rest pain

    Rest pain will be measured using rest pain scale (0 to 10)

    24 months

  • Healing of ulcerations or reduction of ulcer area in the target limb

    Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.

    24 months

Secondary Outcomes (10)

  • Pain free walking distance

    6 and 24 months

  • Major amputation free survival

    6 and 24 months

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

    6 and 24 months

  • Increase in transcutaneous partial oxygen pressure (TcPO2)

    6 and 24 months

  • Quality of life by King's College VascuQOL questionnaire

    6 and 24 months

  • +5 more secondary outcomes

Study Arms (3)

Low dose

EXPERIMENTAL

Stempeucel - CLI will be administered at the lowest dose

Biological: Allogeneic Mesenchymal Stem Cells

Intermediate dose

EXPERIMENTAL

Stempeucel - CLI will be administered at intermediate dose

Biological: Allogeneic Mesenchymal Stem Cells

Control arm

NO INTERVENTION

Standard protocol of care alone

Interventions

Allogeneic Mesenchymal Stem CellsBIOLOGICAL

Single intramuscular administration of low dose of stem cells

Also known as: Stempeucel - CLI
Low dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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, who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients)
  • Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 50 mm Hg or TcPO2 ≤ 40 mmHg in the foot of the study limb
  • 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 transmetatarsal 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 deep vein thrombosis 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 participated in any stem cell clinical trial
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity

Gurgaon, Haryana, 122001, India

Location

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

Bangalore, Karnataka, 560066, India

Location

Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research

Bangalore, Karnataka, 560069, India

Location

Department of Surgery, KMC, Mangalore

Mangalore, Karnataka, 575001, 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

Department of Vascular Surgery, Stanley Medical College

Chennai, Tamil Nadu, 91-44-24732266, India

Location

Department of Vascular Surgery, AMRI Hospital

Kolkata, West Bengal, 700029, India

Location

Nightingale Hospital

Kolkata, West Bengal, 700071, India

Location

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaThromboangiitis Obliterans

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemiaVasculitis

Study Officials

  • Dr Anirban Chatterjee

    AMRI Hospital

    PRINCIPAL INVESTIGATOR

  • Dr Anita Dhar

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Dr Rajkumar M

    Stanley Medical College

    PRINCIPAL INVESTIGATOR

  • Dr Radhakrishnan R

    Sri Ramchandra Medical College

    PRINCIPAL INVESTIGATOR

  • Dr Vidyasagaran T

    Madras Medical College

    PRINCIPAL INVESTIGATOR

  • Dr Alfred Augustine

    KMC, Mangalore

    PRINCIPAL INVESTIGATOR

  • Dr Sanjay Desai

    M. S. Ramaiah Medical College

    PRINCIPAL INVESTIGATOR

  • Dr Rajiv Parakh

    Medanta - The Medicity

    PRINCIPAL INVESTIGATOR

  • Dr Santanu Dutta

    Nightingale Hospital

    PRINCIPAL INVESTIGATOR

  • Dr Murali Krishna

    Sri Jayadeva Institute of Cardiovascular Sciences & Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2011

First Posted

December 2, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

March 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

IN(10)