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

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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

Tracking Information
First Submitted Date  ICMJE November 30, 2015
First Posted Date  ICMJE December 2, 2015
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE August 2006
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease
Official Title  ICMJE Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Leg Ulcer
  • Sickle Cell Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Biological: Infusion of Autologous Bone Marrow Mononuclear Cells
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 1, 2015)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02619734
Other Study ID Numbers  ICMJE 11738
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vitor Fortuna, Federal University of Bahia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Federal University of Bahia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Oswaldo Cruz Foundation
Investigators  ICMJE
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
PRS Account Federal University of Bahia
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP