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Cell Therapy for Venous Leg Ulcers Pilot Study

This study is currently recruiting participants.
Verified May 2013 by Hospital de Clínicas Dr. Manuel Quintela
Sponsor:
Information provided by (Responsible Party):
Cristina Touriño, MD, PhD, Hospital de Clínicas Dr. Manuel Quintela
ClinicalTrials.gov Identifier:
NCT01750749
First received: December 13, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Venous Ulcer
 Biological: Autologous BMDC implantation at the venous ulcer
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Derived Cells in the Treatment of Venous Leg Ulcers Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clínicas Dr. Manuel Quintela:

Primary Outcome Measures:
  • Reduction of the ulcer area at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Measurement of the ulcer area (cm2) and comparison with baseline.

  • Reduction of the ulcer area at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measurement of the ulcer area (cm2) and comparison with baseline.

  • Reduction of the ulcer area at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measurement of the ulcer area (cm2) and comparison with baseline.


Secondary Outcome Measures:
  • Pain reduction at 2 months [ Time Frame: 2 months after intervention ] [ Designated as safety issue: No ]
    Assess of pain by visual analog score

  • Pain reduction at 4 months [ Time Frame: 4 months after intervention ] [ Designated as safety issue: No ]
    Assess of pain by visual analog score

  • Pain reduction at 6 months [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
    Assess of pain by visual analog score

  • Absence of adverse events related with the intervention [ Time Frame: From date of cells implantation until the date of the event, assesed up to 7 days ] [ Designated as safety issue: Yes ]
    Clinical examination of the site of cells implantation for signs of infection, hematoma, edema or eczema. Asses of pain by visual analog score.


Estimated Enrollment: 6
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750749

Contacts
Contact: Cristina Touriño, MD, PhD +59824871515 ext 2517 ctourino@hc.edu.uy
Contact: Gabriela Otero, MD +59824871515 ext 2321 gabyoter@gmail.com

Locations
Uruguay
Universidad de la República- Hospital de Clínicas Dr. Manuel Quintela Recruiting
Montevideo, Uruguay, 11600
Contact: Cristina Touriño     +59824871515 ext 2517        
Contact: Gabriela Otero     +59824871515 ext 2321        
Principal Investigator: Gabriela Otero, MD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Cristina Touriño, MD, PhD, Coordinator of the "Área de Terapia Celular y Medicina Regenerativa", Hospital de Clínicas Dr. Manuel Quintela
ClinicalTrials.gov Identifier: NCT01750749     History of Changes
Other Study ID Numbers: TUV2011
Study First Received: December 13, 2012
Last Updated: May 14, 2013
Health Authority: Uruguay: Ministry of Health

Keywords provided by Hospital de Clínicas Dr. Manuel Quintela:
Venous ulcer
Cell therapy

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
 Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013