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Status unknownNCT02448121Updated Nov 20, 2017

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

A Phase 1/2 interventional study of Autologous bone marrow stem cell graft in Avascular Necrosis of Bone and Sickle Cell Disease, sponsored by Federal University of Bahia. Status unknown. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by Federal University of Bahia · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
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Study summary

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

Read the detailed 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.

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Conditions studied

  • Avascular Necrosis of Bone
  • Sickle Cell Disease

Keywords

  • Cell therapy
  • Sickle cell disease
  • Hip Osteonecrosis
  • Autologous implantation
  • Mesenchymal stromal cell
  • Humeral Osteonecrosis
  • Knee Osteonecrosis
  • Ankle Osteonecrosis
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In context

Osteonecrosis

182 studies on the registry are indexed under Osteonecrosis; 31 are open to participants now.

This study's planned enrollment of 100 is above the median of 51 across 96 interventional studies indexed under Osteonecrosis.

Browse Osteonecrosis studies →

Lead sponsor

Federal University of Bahia is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Autologous bone marrow stem cell graft

    Autologous bone marrow stem cell implantation

    Procedure: Autologous bone marrow stem cell graft

Interventions

  • ProcedureAutologous bone marrow stem cell graft

    All patients will undergo autologous bone marrow stem cell implantation into the necrotic lesion area using a minimally invasive technique.

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What researchers measure

Primary outcomes

  1. Change in Functional / Clinical Score of 10 points or more

    Standardized and objective scoring system to rate patient's functional abilities

    Time frame: 60 months

Secondary outcomes

  1. Numeric pain intensity scale (0-10)

    VAS scoring system

    Time frame: 60 months

  2. Disease progression defined as progression to a fractural stage of osteonecrosis

    Radiographic signals

    Time frame: 60 months

  3. Reoperation rate

    Need for further surgery or hip replacement

    Time frame: 60 months

  4. Radiological progression

    Radiological progression is defined according to the development of the Ficat- and Steinberg-staging system of osteonecrosis. It is based on radiological findings in X-Ray and MRI scans, respectively, and it is useful in predicting outcomes.

    Time frame: 60 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hernigou P, Daltro G, Filippini P, Mukasa MM, Manicom O. Percutaneous implantation of autologous bone marrow osteoprogenitor cells as treatment of bone avascular necrosis related to sickle cell disease. Open Orthop J. 2008 Apr 25;2:62-5. doi: 10.2174/1874325000802010062. PubMed 19478932 ↗
  • Hernigou P, Daltro G, Flouzat-Lachaniette CH, Roussignol X, Poignard A. Septic arthritis in adults with sickle cell disease often is associated with osteomyelitis or osteonecrosis. Clin Orthop Relat Res. 2010 Jun;468(6):1676-81. doi: 10.1007/s11999-009-1149-3. Epub 2009 Nov 3. PubMed 19885711 ↗
  • Hernigou P, Flouzat-Lachaniette CH, Daltro G, Galacteros F. Talar Osteonecrosis Related to Adult Sickle Cell Disease: Natural Evolution from Early to Late Stages. J Bone Joint Surg Am. 2016 Jul 6;98(13):1113-21. doi: 10.2106/JBJS.15.01074. PubMed 27385685 ↗
  • 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. PubMed 26021713 ↗
  • Daltro G, Franco BA, Faleiro TB, Rosario DAV, Daltro PB, Meyer R, Fortuna V. Use of autologous bone marrow stem cell implantation for osteonecrosis of the knee in sickle cell disease: a preliminary report. BMC Musculoskelet Disord. 2018 May 22;19(1):158. doi: 10.1186/s12891-018-2067-x. PubMed 29788942 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02448121
Lead sponsor
Federal University of Bahia
Collaborators
Hospital Universitário Professor Edgard Santos, Oswaldo Cruz Foundation
Responsible party
Vitor Fortuna (PhD, Federal University of Bahia) — Principal investigator
First posted
May 19, 2015
Start date
Aug 2006
Primary completion
Jul 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Nov 20, 2017

Study contacts

GIldasio Daltro, MD
study director · Federal University of Bahia
Vitor Fortuna, PhD
principal investigator · Federal University of Bahia
Roberto Meyer, MD
study chair · Federal University of Bahia
Radovan Borojevic, PhD
study chair · Federal University of Bahia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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