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

November 17, 2017 updated by: Vitor Fortuna, Federal University of Bahia

Treatment for Hip, Knee, Ankle and Shoulder Osteonecrosis With Autologous Mononuclear Cells Transplantation in People With Sickle Cell Disease

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous bone marrow stem cell graft
Autologous bone marrow stem cell implantation
Procedure: Autologous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional / Clinical Score of 10 points or more
Time Frame: 60 months
Standardized and objective scoring system to rate patient's functional abilities
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain intensity scale (0-10)
Time Frame: 60 months
VAS scoring system
60 months
Disease progression defined as progression to a fractural stage of osteonecrosis
Time Frame: 60 months
Radiographic signals
60 months
Reoperation rate
Time Frame: 60 months
Need for further surgery or hip replacement
60 months
Radiological progression
Time Frame: 60 months
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.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Bahia

Collaborators

Oswaldo Cruz Foundation
Hospital Universitário Professor Edgard Santos

Investigators

  • Principal Investigator: Vitor Fortuna, PhD, Federal University of Bahia
  • Study Chair: Roberto Meyer, MD, Federal University of Bahia
  • Study Chair: Radovan Borojevic, PhD, Federal University of Bahia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 25000039812/2005-99
  • 11738 (CONEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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