NCT01903044

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

July 10, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

July 10, 2013

Last Update Submit

December 11, 2017

Conditions

Lower Extremity IschemiaLeg UlcerPeripheral Vascular DiseaseDiabetic FootGangrene

Keywords

Lowe extremity ischemiaBone marrowNeoangiogenesis

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (5)

  • Clinical outcome classification

    3 months, 6 months

  • Pain and analgesics use

    3 months

  • Quality of life outcome

    3 months, 6 months

  • Improvement of the coronary and collateral circulation.

    3 months

  • Survival without amputation

    6 months

Study Arms (1)

BM-MNC injection

EXPERIMENTAL

Injection of autologous bone marrow-derived mononuclear cells

Procedure: BM-MNC injection

Interventions

BM-MNC injectionPROCEDURE

BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles

BM-MNC injection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, 80215-901, Brazil

Location

MeSH Terms

Conditions

Leg UlcerPeripheral Vascular DiseasesDiabetic FootGangreneNeovascularization, Pathologic

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesVascular DiseasesCardiovascular DiseasesDiabetic AngiopathiesFoot UlcerDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsMetaplasia

Study Officials

  • Paulo Brofman, PhD

    Pontifícia Universidade Católica do Paraná

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 19, 2013

Study Start

September 1, 2014

Primary Completion

March 1, 2017

Study Completion

September 1, 2018

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

BR(1)