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

F

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Autologous bone marrow stem cell graft
Experimental group
Description:
Autologous bone marrow stem cell implantation
Treatment:
Procedure: Autologous bone marrow stem cell graft

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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