Cell Therapy for Venous Leg Ulcers Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Venous Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Autologous BMDC implantation at the venous ulcer

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No