Overview

This trial is active, not recruiting.

Condition venous ulcer
Treatment autologous bmdc implantation at the venous ulcer
Phase phase 1
Sponsor Hospital de Clínicas Dr. Manuel Quintela
Start date May 2011
End date December 2013
Trial size 4 participants
Trial identifier NCT01750749, TUV2011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Autologous BMDC implantation at the venous ulcer in conjunction with SOC treatment (advanced wound management plus pressure therapy)
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.

Primary Outcomes

Measure
Reduction of the ulcer area at 2 months
time frame: 2 months
Reduction of the ulcer area at 4 months
time frame: 4 months
Reduction of the ulcer area at 6 months
time frame: 6 months

Secondary Outcomes

Measure
Pain reduction at 2 months
time frame: 2 months after intervention
Pain reduction at 4 months
time frame: 4 months after intervention
Pain reduction at 6 months
time frame: 6 months after intervention
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

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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.

Additional Information

Official title Autologous Bone Marrow Derived Cells in the Treatment of Venous Leg Ulcers Pilot Study
Principal investigator Gabriela Otero, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Hospital de Clínicas Dr. Manuel Quintela.