Clinical trial NCT01903044: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lower Extremity Ischemia
Leg Ulcer
Peripheral Vascular Disease
Diabetic Foot
Gangrene
Keywords: Lowe extremity ischemia
Bone marrow
Neoangiogenesis
Lead sponsor: Pontifícia Universidade Católica do Paraná
Sponsor class: OTHER
Collaborators: name: Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil
name: Hospital Sao Rafael
name: Hospital Geral Nacional Enrique Cabrera, Cuba
name: Instituto de Hematología e Inmunología, Cuba
name: Fundação Araucária
First posted: 2013-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions
timeFrame: 3 months
Secondary outcomes:
measure: Clinical outcome classification
timeFrame: 3 months, 6 months
measure: Pain and analgesics use
timeFrame: 3 months
measure: Quality of life outcome
timeFrame: 3 months, 6 months
measure: Improvement of the coronary and collateral circulation.
timeFrame: 3 months
measure: Survival without amputation
timeFrame: 6 months
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Pontifícia Universidade Católica do Paraná
state: Paraná
Study officials:
affiliation: Pontifícia Universidade Católica do Paraná
name: Paulo Brofman, PhD
role: PRINCIPAL_INVESTIGATOR
References: