Cell Therapy for Venous Leg Ulcers Pilot Study

NCT01750749 | Completed Phase 1

• 1 other identifier: TUV2011
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Ulcer

Keywords

Venous ulcer; Cell therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Pain reduction at 2 months

  2 months after intervention

• Pain reduction at 4 months

  4 months after intervention

• Pain reduction at 6 months

  6 months after intervention

• Absence of adverse events related with the intervention

  From date of cells implantation until the date of the event, assesed up to 7 days

Study Arms (1)

Autologous BMDC implantation at the venous ulcer

EXPERIMENTAL

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

Interventions

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.

Autologous BMDC implantation at the venous ulcer

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clínicas Dr. Manuel Quintela: lead

Study Sites (1)

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

Montevideo, 11600, Uruguay

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Study Officials

• Gabriela Otero, MD

  Cátedra de Dermatología

  PRINCIPAL INVESTIGATOR

• Cristina Touriño, MD, PhD

  Área de Terapia Celular y Medicina Regenerativa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

UR (1)