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

Phase 1

• Conditions: Sickle Cell Disease; Chronic Leg Ulcer
• Interventions: Biological: Infusion of Autologous Bone Marrow Mononuclear Cells

• Registration Number: NCT02619734
• Lead Sponsor: Federal University of Bahia

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 Timeline

• Study Start: 2006-08
• Status Verified: 2015-11
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Study First Posted: 2015-12-02
• Last Update Posted: 2015-12-02
• Primary Completion: 2016-07
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell Injection	Infusion of Autologous Bone Marrow Mononuclear Cells	Intramuscular implantation of Autologous bone marrow-derived mononuclear cells

Primary Outcome Measures

Name	Time	Method
Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events	6 months	Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Change in Leg Ulcer	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 Outcome Measures

Name	Time	Method
Numeric pain intensity scale (0-10)	6 months to one year	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
Ulcer Healing	6 months to one year	Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded
Quality of Life	6 months to one year	Change in quality of life as well as other indicators of patient comfort and well-being