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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Leg Ulcer Sickle Cell Disease||Biological: Infusion of Autologous Bone Marrow Mononuclear Cells||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
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
|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|