Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Time Frame: 6 months
Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Change in Leg Ulcer
Time Frame: 6 months to one year
Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded
Secondary Outcomes
- Numeric pain intensity scale (0-10)(6 months to one year)
- Ulcer Healing(6 months to one year)
- Quality of Life(6 months to one year)
Investigators
Vitor Fortuna
PhD
Federal University of Bahia