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

Sickle Cell Disease Clinical Trial

Official title:

Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02619734
• Other study ID #: 11738
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: November 30, 2015
• Last updated: December 1, 2015
• Start date: August 2006
• Est. completion date: August 2016

Study information

• Verified date: November 2015
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Chronic Leg Ulcer
• Leg Ulcer
• Sickle Cell Disease
• Skin Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Bahia	Oswaldo Cruz Foundation

References & Publications (1)

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;6:110. doi: 10.1186/s13287-015-0105-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events	Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events	6 months	Yes
Primary	Change in Leg Ulcer	Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded	6 months to one year	No
Secondary	Numeric pain intensity scale (0-10)	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	6 months to one year	No
Secondary	Ulcer Healing	Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded	6 months to one year	No
Secondary	Quality of Life	Change in quality of life as well as other indicators of patient comfort and well-being	6 months to one year	No