Clinical trial NCT02619734: Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease
Official title: Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Leg Ulcer
Sickle Cell Disease
Keywords: Cell Therapy
Sickle cell disease
Autologous implantation
Mesenchymal stromal cell
Edothelial Progenitor cell
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
Collaborators: name: Oswaldo Cruz Foundation
First posted: 2015-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
timeFrame: 6 months
measure: Change in Leg Ulcer
timeFrame: 6 months to one year
Secondary outcomes:
measure: Numeric pain intensity scale (0-10)
timeFrame: 6 months to one year
measure: Ulcer Healing
timeFrame: 6 months to one year
measure: Quality of Life
timeFrame: 6 months to one year
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Bahia
name: José Valber Meneses, MD
role: STUDY_CHAIR
affiliation: Federal University of Bahia
name: Gildasio Daltro, MD
role: STUDY_DIRECTOR
affiliation: Federal University of Bahia
name: Vitor A Fortuna, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daltro GC, Fortuna V, de Souza ES, Salles MM, Carreira AC, Meyer R, Freire SM, Borojevic R. Efficacy of autologous stem cell-based therapy for osteonecrosis of the femoral head in sickle cell disease: a five-year follow-up study. Stem Cell Res Ther. 2015 May 29;6(1):110. doi: 10.1186/s13287-015-0105-2.