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Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating

Primary Purpose

Lower Extremity Ischemia, Leg Ulcer, Peripheral Vascular Disease

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
BM-MNC injection
Sponsored by
Pontifícia Universidade Católica do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Extremity Ischemia focused on measuring Lowe extremity ischemia, Bone marrow, Neoangiogenesis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing.
  • Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization.
  • Patients considered at high risk for new revascularization procedure by at least two independent observers.

Exclusion Criteria:

  • Expected life span less than six months
  • Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term.
  • Evidence of osteomyelitis in the ischemic extremity.
  • Current or previous history of neoplasia.
  • Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration.
  • Proliferative retinopathy.
  • Debilitating disease with a life span less than one year.
  • Myelofibrosis, myelodysplasia or other diseases that affect the bone marrow.
  • Use of alcohol in excess of twice-daily doses or history of illicit drug use.
  • Need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day).
  • Positivity for HIV or syphilis

Sites / Locations

  • Pontifícia Universidade Católica do Paraná

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BM-MNC injection

Arm Description

Injection of autologous bone marrow-derived mononuclear cells

Outcomes

Primary Outcome Measures

Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions

Secondary Outcome Measures

Clinical outcome classification
Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI
Pain and analgesics use
Quality of life outcome
Improvement of the coronary and collateral circulation.
Survival without amputation

Full Information

First Posted
July 10, 2013
Last Updated
December 11, 2017
Sponsor
Pontifícia Universidade Católica do Paraná
Collaborators
Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil, Hospital Sao Rafael, Hospital Geral Nacional Enrique Cabrera, Cuba, Instituto de Hematología e Inmunología, Cuba, Fundação Araucária
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1. Study Identification

Unique Protocol Identification Number
NCT01903044
Brief Title
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
Official Title
Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontifícia Universidade Católica do Paraná
Collaborators
Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil, Hospital Sao Rafael, Hospital Geral Nacional Enrique Cabrera, Cuba, Instituto de Hematología e Inmunología, Cuba, Fundação Araucária

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
Detailed Description
Critical limb ischemia (CLI) is a debilitating and disabling disease. Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Ischemia, Leg Ulcer, Peripheral Vascular Disease, Diabetic Foot, Gangrene
Keywords
Lowe extremity ischemia, Bone marrow, Neoangiogenesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BM-MNC injection
Arm Type
Experimental
Arm Description
Injection of autologous bone marrow-derived mononuclear cells
Intervention Type
Procedure
Intervention Name(s)
BM-MNC injection
Intervention Description
BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles
Primary Outcome Measure Information:
Title
Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical outcome classification
Description
Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI
Time Frame
3 months, 6 months
Title
Pain and analgesics use
Time Frame
3 months
Title
Quality of life outcome
Time Frame
3 months, 6 months
Title
Improvement of the coronary and collateral circulation.
Time Frame
3 months
Title
Survival without amputation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing. Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization. Patients considered at high risk for new revascularization procedure by at least two independent observers. Exclusion Criteria: Expected life span less than six months Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term. Evidence of osteomyelitis in the ischemic extremity. Current or previous history of neoplasia. Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration. Proliferative retinopathy. Debilitating disease with a life span less than one year. Myelofibrosis, myelodysplasia or other diseases that affect the bone marrow. Use of alcohol in excess of twice-daily doses or history of illicit drug use. Need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day). Positivity for HIV or syphilis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Brofman, PhD
Organizational Affiliation
Pontifícia Universidade Católica do Paraná
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontifícia Universidade Católica do Paraná
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80215-901
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating

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