Cell Therapy for Venous Leg Ulcers Pilot Study

Phase 1

Completed

• Conditions: Venous Ulcer
• Interventions: Biological: Autologous BMDC implantation at the venous ulcer

• Registration Number: NCT01750749
• Lead Sponsor: Hospital de Clínicas Dr. Manuel Quintela

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous BMDC implantation at the venous ulcer	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)

Primary Outcome Measures

Name	Time	Method
Reduction of the ulcer area at 6 months	6 months	Measurement of the ulcer area (cm2) and comparison with baseline.
Reduction of the ulcer area at 2 months	2 months	Measurement of the ulcer area (cm2) and comparison with baseline.
Reduction of the ulcer area at 4 months	4 months	Measurement of the ulcer area (cm2) and comparison with baseline.

Secondary Outcome Measures

Name	Time	Method
Absence of adverse events related with the intervention	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.
Pain reduction at 2 months	2 months after intervention	Assess of pain by visual analog score
Pain reduction at 4 months	4 months after intervention	Assess of pain by visual analog score
Pain reduction at 6 months	6 months after intervention	Assess of pain by visual analog score

Trial Locations

Locations (1)

Universidad de la República- Hospital de Clínicas Dr. Manuel Quintela; 🇺🇾 Montevideo, Uruguay