Clinical trial NCT01750749: Cell Therapy for Venous Leg Ulcers Pilot Study
Official title: Autologous Bone Marrow Derived Cells in the Treatment of Venous Leg Ulcers Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Venous Ulcer
Keywords: Venous ulcer
Cell therapy
Lead sponsor: Hospital de Clínicas Dr. Manuel Quintela
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Reduction of the ulcer area at 2 months
timeFrame: 2 months
measure: Reduction of the ulcer area at 4 months
timeFrame: 4 months
measure: Reduction of the ulcer area at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Pain reduction at 2 months
timeFrame: 2 months after intervention
measure: Pain reduction at 4 months
timeFrame: 4 months after intervention
measure: Pain reduction at 6 months
timeFrame: 6 months after intervention
measure: Absence of adverse events related with the intervention
timeFrame: From date of cells implantation until the date of the event, assesed up to 7 days
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Universidad de la República- Hospital de Clínicas Dr. Manuel Quintela
Study officials:
affiliation: Cátedra de Dermatología
name: Gabriela Otero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Área de Terapia Celular y Medicina Regenerativa
name: Cristina Touriño, MD, PhD
role: STUDY_DIRECTOR
References: