A Phase 1 interventional study of Autologous BMDC implantation at the venous ulcer in Venous Ulcer, sponsored by Hospital de Clínicas Dr. Manuel Quintela. Completed at 1 site in Uruguay. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-06.
Sponsored by Hospital de Clínicas Dr. Manuel Quintela · Phase 1, Interventional, and Treatment
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.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 4 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Hospital de Clínicas Dr. Manuel Quintela is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Reduction of the ulcer area at 2 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Time frame: 2 months
Reduction of the ulcer area at 4 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Time frame: 4 months
Reduction of the ulcer area at 6 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Time frame: 6 months
Pain reduction at 2 months
Assess of pain by visual analog score
Time frame: 2 months after intervention
Pain reduction at 4 months
Assess of pain by visual analog score
Time frame: 4 months after intervention
Pain reduction at 6 months
Assess of pain by visual analog score
Time frame: 6 months after intervention
Absence of adverse events related with the intervention
Clinical examination of the site of cells implantation for signs of infection, hematoma, edema or eczema. Asses of pain by visual analog score.
Time frame: From date of cells implantation until the date of the event, assesed up to 7 days
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Hospital de Clínicas Dr. Manuel Quintela