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Completed

NCT Number: NCT01750749

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.

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Key information

Conditions

Venous Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universidad de la República- Hospital de Clínicas Dr. Manuel Quintela

Montevideo, 11600, Uruguay

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous BMDC implantation at the venous ulcer

Biological

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

  1. Reduction of the ulcer area at 2 months

    Time frame: 2 months

    Measurement of the ulcer area (cm2) and comparison with baseline.

  2. Reduction of the ulcer area at 4 months

    Time frame: 4 months

    Measurement of the ulcer area (cm2) and comparison with baseline.

  3. Reduction of the ulcer area at 6 months

    Time frame: 6 months

    Measurement of the ulcer area (cm2) and comparison with baseline.

Secondary outcomes

  1. Pain reduction at 2 months

    Time frame: 2 months after intervention

    Assess of pain by visual analog score

  2. Pain reduction at 4 months

    Time frame: 4 months after intervention

    Assess of pain by visual analog score

  3. Pain reduction at 6 months

    Time frame: 6 months after intervention

    Assess of pain by visual analog score

  4. 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.

Sponsors and collaborators

Lead sponsor

Hospital de Clínicas Dr. Manuel Quintela

Other

Registry information

Official study title

Autologous Bone Marrow Derived Cells in the Treatment of Venous Leg Ulcers Pilot Study

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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