Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease

Phase 1UnknownNCT02619734

Federal University of Bahia40 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.

Implantation of bone marrow mononuclear cells, including endothelial progenitor cells and mesenchymal stromal cells, into leg ulcers has been shown to improve wound healing. In the present study the safety and efficacy of autologous bone marrow mononuclear cells implantation will be investigated in patients with chronic leg ulcers. Forty cases will be enrolled. Improvement in the pain, rate and extent of leg ulcer wound healing as measured by change in wound surface area will be evaluated until one year.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Leg Ulcer Sickle Cell Disease

Interventions

Infusion of Autologous Bone Marrow Mononuclear CellsBIOLOGICAL

Autologous bone marrow-derived mononuclear cells will be administered by intramuscular injection into and around the leg ulcer. The number of injected cells will be from 5x108 to 1x109 total number of cells on Study Day 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stable sickle cell disease patients * Patient hospitalized into the dermatology unit * Patient with an evolutive leg ulcer since more than 1 year * No infection at the time of surgery * Patient competent to give informed consent Exclusion Criteria: * Patients with a history of corticosteroids or on active therapy * infection at the limb affected by ulcer * Recurrent painful crises, * Immunosuppressive drug therapy, * Pregnancy, * Presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of leg ulcer

Outcomes

Primary Outcomes

Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events

Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events

Time frame: 6 months

Change in Leg Ulcer

Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded

Time frame: 6 months to one year

Secondary Outcomes

Numeric pain intensity scale (0-10)

Change in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale (analogic visual scale) and relative to non-wound site pain scores

Time frame: 6 months to one year

Ulcer Healing

Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded

Time frame: 6 months to one year

Quality of Life

Change in quality of life as well as other indicators of patient comfort and well-being

Time frame: 6 months to one year

Data from ClinicalTrials.gov

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