Cell Therapy for Venous Leg Ulcers Pilot Study

Venous Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750749
• Other study ID #: TUV2011
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2012
• Last updated: March 2, 2017
• Start date: May 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2017
• Source: Hospital de Clínicas Dr. Manuel Quintela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

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.

Locations

Country	Name	City	State
Uruguay	Universidad de la República- Hospital de Clínicas Dr. Manuel Quintela	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clínicas Dr. Manuel Quintela

Country where clinical trial is conducted

Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the ulcer area at 2 months	Measurement of the ulcer area (cm2) and comparison with baseline.	2 months
Primary	Reduction of the ulcer area at 4 months	Measurement of the ulcer area (cm2) and comparison with baseline.	4 months
Primary	Reduction of the ulcer area at 6 months	Measurement of the ulcer area (cm2) and comparison with baseline.	6 months
Secondary	Pain reduction at 2 months	Assess of pain by visual analog score	2 months after intervention
Secondary	Pain reduction at 4 months	Assess of pain by visual analog score	4 months after intervention
Secondary	Pain reduction at 6 months	Assess of pain by visual analog score	6 months after intervention
Secondary	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