Peripheral Vascular DiseasesPhase 1NCT00306085
Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis
A Phase 1 study testing Autologous bone marrow cells in people with Peripheral Vascular Diseases, run by University of Naples at 1 site in Italy.
Trial summary
Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Autologous bone marrow cells
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2005to Apr 2006
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of third or fourth class of peripheral atherosclerosis
Who cannot join
- Insuline dependent diabetes
- Cancer
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Naples
Naples, 80134
Maria Carmela Corbisiero, +39081/5665681, marika_corbi@inwind.it
About this study
Official title: Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis
Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Autologous bone marrow cells
- Keywords
- Peripheral arterial disease,, blood marrow cells,, therapeutic angiogenesis.
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow cellsGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
Secondary outcomes (1)
Angiographic and laser doppler measurements after six months from treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startApr 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Investigators
- Vincenzo Sica, Study director, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306085
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2006
- First submitted
- 14 Mar 2006
- Last updated
- 22 Mar 2006
- Results posted
- No
Publications
Maione C, Botti C, Coppola CA, Silvestroni C, Lillo S, Schiavone V, Sica G, Sica V, Kumar V, Cobellis G. Effect of autologous transplantation of bone marrow cells concentrated with the MarrowXpress system in patients with critical limb ischemia. Transplant Proc. 2013 Jan-Feb;45(1):402-6. doi: 10.1016/j.transproceed.2012.10.031.
PubMed 23375329Cobellis G, Botti C, Taddeo A, Silvestroni A, Lillo S, Da Ponte A, Villa ML, Sica V, Della Bella S. Successful bone marrow transplantation reveals the lack of endothelial progenitor cells mobilization in a patient with critical limb ischemia: a case report. Transplant Proc. 2010 Sep;42(7):2816-20. doi: 10.1016/j.transproceed.2010.04.047.
PubMed 20832596Napoli C, Farzati B, Sica V, Iannuzzi E, Coppola G, Silvestroni A, Balestrieri ML, Florio A, Matarazzo A. Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):709-18. doi: 10.1097/HJR.0b013e3283193a0f.
PubMed 19050436
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis
- ClinicalTrials.gov ID
- NCT00306085
- Acronym / sponsor ID
- 1
- Conditions
- Peripheral Vascular Diseases
- Keywords
- Peripheral arterial disease,, blood marrow cells,, therapeutic angiogenesis.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Apr 2006
- First posted
- 22 Mar 2006 (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.
Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of third or fourth class of peripheral atherosclerosis
Key exclusion criteria (2 listed)
- Insuline dependent diabetes
- Cancer
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 bone marrow cells | Genetic | – |
Primary outcome
Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
1 secondary outcome
Angiographic and laser doppler measurements after six months from treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2006.
- Derived from this study: PubMed 23375329Maione C, Botti C, Coppola CA, Silvestroni C, Lillo S, Schiavone V, Sica G, Sica V, Kumar V, Cobellis G. Effect of autologous transplantation of bone marrow cells concentrated with the MarrowXpress system in patients with critical limb ischemia. Transplant Proc. 2013 Jan-Feb;45(1):402-6. doi: 10.1016/j.transproceed.2012.10.031.
- Derived from this study: PubMed 20832596Cobellis G, Botti C, Taddeo A, Silvestroni A, Lillo S, Da Ponte A, Villa ML, Sica V, Della Bella S. Successful bone marrow transplantation reveals the lack of endothelial progenitor cells mobilization in a patient with critical limb ischemia: a case report. Transplant Proc. 2010 Sep;42(7):2816-20. doi: 10.1016/j.transproceed.2010.04.047.
- Derived from this study: PubMed 19050436Napoli C, Farzati B, Sica V, Iannuzzi E, Coppola G, Silvestroni A, Balestrieri ML, Florio A, Matarazzo A. Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):709-18. doi: 10.1097/HJR.0b013e3283193a0f.
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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.
Vincenzo Sica study director
University of Naples
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 bone marrow cells in people with Peripheral Vascular Diseases, run by University of Naples at 1 site in Italy.
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 1 inclusion and 2 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 22 Mar 2006. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Eisele (+39 081/5665685, heidi.eisele@unina2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00306085, which also lists 3 linked publications.
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 22 Mar 2006.