Venous Ulcer
Conditions
Keywords
Venous ulcer, Cell therapy
Brief summary
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.
Interventions
BIOLOGICALAutologous 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.
Sponsors
Hospital de Clínicas Dr. Manuel Quintela
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age from 40 to 75 years * Patients with primary venous insufficiency * Patients with venous ulcers with area larger than 2 cm2, who have received SOC treatment in the previous three months. * Ulcers with negative bacterial cultures or with polymicrobial flora.
Exclusion criteria
* Patients with decompensated heart failure. * Patients with lower limb edema of nonvenous etiology. * Patients with diagnosis of diabetes mellitus. * Patients with body mass index (BMI) ≤ 18.5 or \> 40.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the ulcer area at 2 months | 2 months | Measurement of the ulcer area (cm2) and comparison with baseline. |
| Reduction of the ulcer area at 4 months | 4 months | Measurement of the ulcer area (cm2) and comparison with baseline. |
| Reduction of the ulcer area at 6 months | 6 months | Measurement of the ulcer area (cm2) and comparison with baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction at 2 months | 2 months after intervention | Assess of pain by visual analog score |
| Pain reduction at 4 months | 4 months after intervention | Assess of pain by visual analog score |
| Pain reduction at 6 months | 6 months after intervention | Assess of pain by visual analog score |
| Absence of adverse events related with the intervention | 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. |
Countries
Uruguay
Outcome results
None listed