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

Federal University of Bahia

Status and phase: Unknown; Phase 1

Conditions: Chronic Leg Ulcer; Sickle Cell Disease

Treatments: Biological: Infusion of Autologous Bone Marrow Mononuclear Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02619734

11738 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

No Intervention group

Description:

Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers

Stem Cell Injection

Experimental group

Description:

Intramuscular implantation of Autologous bone marrow-derived mononuclear cells

Treatment:

Biological: Infusion of Autologous Bone Marrow Mononuclear Cells