Autologous Bone Marrow Stem Cell Transplantation for Osteonecrosis in Sickle Cell Disease

Federal University of Bahia

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Sickle Cell Disease

Avascular Necrosis of Bone

Treatments

Procedure: Autologous bone marrow stem cell graft

Study type

Interventional

Funder types

Other

Identifiers

NCT02448121

CAAE 25000039812/2005-99

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 cells in sickle cell disease patients with osteonecrosis

Full description

The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for sickle cell disease patients with osteonecrosis.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Stable sickle cell disease patients
FICAT classification of osteonecrosis, inclusive of Stage II.
Diagnosis will be based on X-Ray and magnetic resonance imaging (MRI).
No infection in affected bones at the time of surgery.
Patient competent to give informed consent.
Scoring at least 20 points on the pain and daily life activities questionnaire.

Exclusion criteria

FICAT stage III or more
Patients with a history of corticosteroids or on active therapy
Bone infection at the limb affected by necrosis
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 osteonecrosis of the femoral head