Cell Therapy for Venous Leg Ulcers Pilot Study

Autologous Bone Marrow Derived Cells in the Treatment of 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.

Study Overview

• Status: Completed
• Conditions: Venous Ulcer
• Intervention / Treatment: Biological: Autologous BMDC implantation at the venous ulcer

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• Uruguay
  • Montevideo, Uruguay, 11600
    • Universidad de la República- Hospital de Clínicas Dr. Manuel Quintela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the ulcer area at 2 months	Measurement of the ulcer area (cm2) and comparison with baseline.	2 months
Reduction of the ulcer area at 4 months	Measurement of the ulcer area (cm2) and comparison with baseline.	4 months
Reduction of the ulcer area at 6 months	Measurement of the ulcer area (cm2) and comparison with baseline.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reduction at 2 months	Assess of pain by visual analog score	2 months after intervention
Pain reduction at 4 months	Assess of pain by visual analog score	4 months after intervention
Pain reduction at 6 months	Assess of pain by visual analog score	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.	From date of cells implantation until the date of the event, assesed up to 7 days

Collaborators and Investigators

• Sponsor: Hospital de Clínicas Dr. Manuel Quintela
• Investigators: Principal Investigator: Gabriela Otero, MD, Cátedra de Dermatología; Study Director: Cristina Touriño, MD, PhD, Área de Terapia Celular y Medicina Regenerativa

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cell therapy; Venous ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: TUV2011