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

NCT ID: NCT02619734

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2016-08-31

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.

Conditions

Chronic Leg Ulcer; Sickle Cell Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Stem Cell Injection

Intramuscular implantation of Autologous bone marrow-derived mononuclear cells

Group Type: EXPERIMENTAL

Infusion of Autologous Bone Marrow Mononuclear Cells

Intervention Type: BIOLOGICAL

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.

Interventions

Infusion of Autologous Bone Marrow Mononuclear Cells

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oswaldo Cruz Foundation

OTHER

Sponsor Role: collaborator

Federal University of Bahia

OTHER

Sponsor Role: lead

Responsible Party

Vitor Fortuna

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Valber Meneses, MD

Role: STUDY_CHAIR

Federal University of Bahia

Gildasio Daltro, MD

Role: STUDY_DIRECTOR

Federal University of Bahia

Vitor A Fortuna, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

References

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.

Reference Type: BACKGROUND

PMID: 26021713 (View on PubMed)

Other Identifiers

11738

Identifier Type: -

Identifier Source: org_study_id