Status:
UNKNOWN
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
Lead Sponsor:
Pontifícia Universidade Católica do Paraná
Collaborating Sponsors:
Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil
Hospital Sao Rafael
Conditions:
Lower Extremity Ischemia
Leg Ulcer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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. Despit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01903044
Start Date
September 1 2014
End Date
September 1 2018
Last Update
December 13 2017
Active Locations (1)
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1
Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, Brazil, 80215-901