Lower Extremity IschemiaPhase 1/2NCT01903044
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
A Phase 1/2 study testing BM-MNC injection in people with Lower Extremity Ischemia and Leg Ulcer, run by Pontifícia Universidade Católica do Paraná at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Extremity Ischemia, Leg Ulcer, Peripheral Vascular Disease
- What is being tested?
- BM-MNC injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Sep 2018
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing.
- Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization.
- Patients considered at high risk for new revascularization procedure by at least two independent observers.
Who cannot join
- Expected life span less than six months
- Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term.
- Evidence of osteomyelitis in the ischemic extremity.
- Current or previous history of neoplasia.
- Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration.
- Proliferative retinopathy.
Show all 11Show fewer
- Debilitating disease with a life span less than one year.
- Myelofibrosis, myelodysplasia or other diseases that affect the bone marrow.
- Use of alcohol in excess of twice-daily doses or history of illicit drug use.
- Need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day).
- Positivity for HIV or syphilis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, 80215-901
About this study
Official title: Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
Read the detailed description
Critical limb ischemia (CLI) is a debilitating and disabling disease. Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target.
- Being tested
- BM-MNC injection
- Keywords
- Lowe extremity ischemia, Bone marrow, Neoangiogenesis
- Medical subject headings
- Leg Ulcer, Peripheral Vascular Diseases, Diabetic Foot, Gangrene, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM-MNC injectionProcedure or surgery
BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles
| Study group | Role | What they receive |
|---|---|---|
| BM-MNC injection | Experimental | Injection of autologous bone marrow-derived mononuclear cells Receives: Procedure: BM-MNC injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions
Measured: 3 months
Secondary outcomes (5)
Clinical outcome classification
Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI
Measured: 3 months, 6 months
Pain and analgesics use
Measured: 3 months
Quality of life outcome
Measured: 3 months, 6 months
Improvement of the coronary and collateral circulation.
Measured: 3 months
Survival without amputation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startSep 2014
- Primary completionMar 2017
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity IschemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontifícia Universidade Católica do Paraná
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil, Hospital Sao Rafael, Hospital Geral Nacional Enrique Cabrera, Cuba, Instituto de Hematología e Inmunología, Cuba, Fundação Araucária
- Responsible party
- Principal investigator, Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná
- Investigators
- Paulo Brofman, PhD, Principal investigator, Pontifícia Universidade Católica do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903044
- Sponsor's protocol ID
- ICMI_ 404732/2012-7
- Status last verified
- Dec 2017
- First submitted
- 10 Jul 2013
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia
- ClinicalTrials.gov ID
- NCT01903044
- Acronym / sponsor ID
- ICMI_ 404732/2012-7
- Keywords
- Lowe extremity ischemia, Bone marrow, Neoangiogenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pontifícia Universidade Católica do ParanáUniversity, hospital or other
- Collaborators
- Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil, Hospital Sao Rafael, Hospital Geral Nacional Enrique Cabrera, Cuba, Instituto de Hematología e Inmunología, Cuba, Fundação Araucária
- Study start
- Sep 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Jul 2013 (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.
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
Detailed description
Critical limb ischemia (CLI) is a debilitating and disabling disease. Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BM-MNC injection | Experimental | Procedure: BM-MNC injectionInjection of autologous bone marrow-derived mononuclear cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing.
- Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization.
- Patients considered at high risk for new revascularization procedure by at least two independent observers.
Key exclusion criteria (11 listed)
- Expected life span less than six months
- Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term.
- Evidence of osteomyelitis in the ischemic extremity.
- Current or previous history of neoplasia.
- Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration.
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 |
|---|---|---|
| BM-MNC injectionBM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles | Procedure or surgery | BM-MNC injection |
Primary outcome
Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions
Time frame: 3 months
5 secondary outcomes
Clinical outcome classification
Time frame: 3 months, 6 months
Pain and analgesics use
Time frame: 3 months
Quality of life outcome
Time frame: 3 months, 6 months
Improvement of the coronary and collateral circulation.
Time frame: 3 months
Survival without amputation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Related trials for Lower Extremity Ischemia
Recruiting
Effectiveness of Theta Burst Stimulation For Upper and Lower Extremity Recovery in Stroke
Ischemic Stroke
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Not yet recruiting
Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
Lower Limb Ischaemia
Recruiting
The ArtixASCEND Study
Acute Lower Limb Arterial Occlusion
Not yet recruiting
Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
Lower Limb Amputation Above Knee, Below Knee Amputation
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.
Paulo Brofman, PhD principal investigator
Pontifícia Universidade Católica do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BM-MNC injection in people with Lower Extremity Ischemia and Leg Ulcer, run by Pontifícia Universidade Católica do Paraná at 1 site in Brazil.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Dec 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 Brazil. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions (time frame: 3 months). 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 13 Dec 2017.