Cell Therapy for Venous Leg Ulcers Pilot Study
Chronic venous leg ulcers (CVU) represent a medical problem associated with significant morbidity, increased work absenteeism and earlier retirement as a consequence of disability. This strongly affects the patient's quality of life and has a significant economic impact on healthcare systems.
Reports of studies with animal models show that treatment with bone marrow-derived stem cells has a beneficial effect in healing chronic skin wounds.
The purpose of this pilot study is to determine the safety and feasibility of cell therapy with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot study will be used to refine the clinical protocol procedures of a subsequent randomized study.
Patients with venous legs ulcers meeting eligibility criteria and providing appropriate written informed consent will be enrolled for study participation. Enrolled patients will receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care (SOC) treatment.
During follow up, adverse events will be assessed by ulcer clinical examination. Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing (reduction of the ulcer area) and pain reduction over a six-month period.
|Venous Ulcer||Biological: Autologous BMDC implantation at the venous ulcer||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Autologous Bone Marrow Derived Cells in the Treatment of Venous Leg Ulcers Pilot Study|
- Reduction of the ulcer area at 2 months [ Time Frame: 2 months ]Measurement of the ulcer area (cm2) and comparison with baseline.
- Reduction of the ulcer area at 4 months [ Time Frame: 4 months ]Measurement of the ulcer area (cm2) and comparison with baseline.
- Reduction of the ulcer area at 6 months [ Time Frame: 6 months ]Measurement of the ulcer area (cm2) and comparison with baseline.
- Pain reduction at 2 months [ Time Frame: 2 months after intervention ]Assess of pain by visual analog score
- Pain reduction at 4 months [ Time Frame: 4 months after intervention ]Assess of pain by visual analog score
- Pain reduction at 6 months [ Time Frame: 6 months after intervention ]Assess of pain by visual analog score
- Absence of adverse events related with the intervention [ Time Frame: From date of cells implantation until the date of the event, assesed up to 7 days ]Clinical examination of the site of cells implantation for signs of infection, hematoma, edema or eczema. Asses of pain by visual analog score.
|Study Start Date:||May 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Autologous BMDC implantation at the venous ulcer
Autologous BMDC implantation at the venous ulcer in conjunction with SOC treatment (advanced wound management plus pressure therapy)
Biological: Autologous BMDC implantation at the venous ulcer
An autologous bone marrow derived cell concentrate is obtained by bone marrow harvest (300 ml) from the iliac crest and subsequent processing using 6% hydroxyethyl starch to concentrate nucleated cells. The cells are injected using a 27 Gauge needle, in aliquots of 0.2 ml, along the venous ulcer edge. SOC treatment consisting of advanced wound management plus pressure therapy is administered simultaneously.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750749
|Universidad de la República- Hospital de Clínicas Dr. Manuel Quintela|
|Montevideo, Uruguay, 11600|
|Principal Investigator:||Gabriela Otero, MD||Cátedra de Dermatología|
|Study Director:||Cristina Touriño, MD, PhD||Área de Terapia Celular y Medicina Regenerativa|