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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619734
Recruitment Status : Unknown
Verified November 2015 by Vitor Fortuna, Federal University of Bahia.
Recruitment status was:  Enrolling by invitation
First Posted : December 2, 2015
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Oswaldo Cruz Foundation
Information provided by (Responsible Party):
Vitor Fortuna, Federal University of Bahia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Leg Ulcer Sickle Cell Disease Biological: Infusion of Autologous Bone Marrow Mononuclear Cells Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients
Study Start Date : August 2006
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers
Experimental: Stem Cell Injection
Intramuscular implantation of Autologous bone marrow-derived mononuclear cells
 Biological: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events [ Time Frame: 6 months ]
    Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events

  2. Change in Leg Ulcer [ Time Frame: 6 months to one year ]
    Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded


Secondary Outcome Measures :
  1. Numeric pain intensity scale (0-10) [ Time Frame: 6 months to one year ]
    Change in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale (analogic visual scale) and relative to non-wound site pain scores

  2. Ulcer Healing [ Time Frame: 6 months to one year ]
    Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded

  3. Quality of Life [ Time Frame: 6 months to one year ]
    Change in quality of life as well as other indicators of patient comfort and well-being


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619734


Sponsors and Collaborators
Federal University of Bahia
Oswaldo Cruz Foundation
Investigators
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Study Chair: José Valber Meneses, MD Federal University of Bahia
Study Director: Gildasio Daltro, MD Federal University of Bahia
Principal Investigator: Vitor A Fortuna, PhD Federal University of Bahia
More Information
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Publications:

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Responsible Party: Vitor Fortuna, PhD, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT02619734    
Other Study ID Numbers: 11738
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Vitor Fortuna, Federal University of Bahia:
Cell Therapy
Sickle cell disease
Autologous implantation
Mesenchymal stromal cell
Edothelial Progenitor cell
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Leg Ulcer
Skin Ulcer
Ulcer
Pathologic Processes
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Skin Diseases