Venous UlcerPhase 1NCT01750749
Cell Therapy for Venous Leg Ulcers Pilot Study
A Phase 1 study testing Autologous BMDC implantation at the venous ulcer in people with Venous Ulcer, run by Hospital de Clínicas Dr. Manuel Quintela at 1 site in Uruguay.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Autologous BMDC implantation at the venous ulcer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUruguay
- Study dates
- May 2011to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uruguay1 site
Universidad de la República- Hospital de Clínicas Dr. Manuel Quintela
Montevideo, 11600
About this study
Official title: Autologous Bone Marrow Derived Cells in the Treatment of Venous Leg Ulcers Pilot Study
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.
Read more
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
- Being tested
- Autologous BMDC implantation at the venous ulcer
- Keywords
- Venous ulcer, Cell therapy
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous BMDC implantation at the venous ulcerBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Autologous BMDC implantation at the venous ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the ulcer area at 2 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Measured: 2 months
Reduction of the ulcer area at 4 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Measured: 4 months
Reduction of the ulcer area at 6 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Measured: 6 months
Secondary outcomes (4)
Pain reduction at 2 months
Assess of pain by visual analog score
Measured: 2 months after intervention
Pain reduction at 4 months
Assess of pain by visual analog score
Measured: 4 months after intervention
Pain reduction at 6 months
Assess of pain by visual analog score
Measured: 6 months after intervention
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.
Measured: From date of cells implantation until the date of the event, assesed up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clínicas Dr. Manuel Quintela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Touriño, MD, PhD, Hospital de Clínicas Dr. Manuel Quintela
- Investigators
- Gabriela Otero, MD, Principal investigator, Cátedra de DermatologíaCristina Touriño, MD, PhD, Study director, Área de Terapia Celular y Medicina Regenerativa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750749
- Sponsor's protocol ID
- TUV2011
- Status last verified
- Mar 2017
- First submitted
- 13 Dec 2012
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Derived Cells in the Treatment of Venous Leg Ulcers Pilot Study
- ClinicalTrials.gov ID
- NCT01750749
- Acronym / sponsor ID
- TUV2011
- Conditions
- Venous Ulcer
- Keywords
- Venous ulcer, Cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospital de Clínicas Dr. Manuel QuintelaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous BMDC implantation at the venous ulcer | Experimental | Biological: Autologous BMDC implantation at the venous ulcerAutologous BMDC implantation at the venous ulcer in conjunction with SOC treatment (advanced wound management plus pressure therapy) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous BMDC implantation at the venous ulcerAn 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. | Biological | Autologous BMDC implantation at the venous ulcer |
Primary outcome
Reduction of the ulcer area at 2 months
Time frame: 2 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Reduction of the ulcer area at 4 months
Time frame: 4 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Reduction of the ulcer area at 6 months
Time frame: 6 months
Measurement of the ulcer area (cm2) and comparison with baseline.
4 secondary outcomes
Pain reduction at 2 months
Time frame: 2 months after intervention
Pain reduction at 4 months
Time frame: 4 months after intervention
Pain reduction at 6 months
Time frame: 6 months after intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Otero, MD principal investigator
Cátedra de Dermatología
Cristina Touriño, MD, PhD study director
Área de Terapia Celular y Medicina Regenerativa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous BMDC implantation at the venous ulcer in people with Venous Ulcer, run by Hospital de Clínicas Dr. Manuel Quintela at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the ulcer area at 2 months (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.