Peripheral Arterial DiseaseNCT00919516
Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease
A study testing Bone marrow mononuclear cell implantation in people with Peripheral Arterial Disease, run by The Vascular and Vein Center, Columbus, OH at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of dual intramuscular and intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of patients with moderate to severe peripheral arterial disease in whom amputation was considered the only viable treatment option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Bone marrow mononuclear cell implantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years of age.
- Patients with moderate or severe limb-threatening PAD, defined as ankle brachial indices (ABI) less than 0.7 or presence of non-healing ischemic ulcers with stenosis or occlusion of two of the following lower extremity arteries: anterior tibial, posterior tibial, and peroneal.
- Patients with conditions that preclude recommendation of traditional endovascular or open bypass treatments.
Who cannot join
- Patients younger than 18 years of age.
- Patients who are eligible to undergo traditional endovascular or open bypass for the treatment of PAD.
- Female patients who are or may be pregnant.
- Patients who are prisoners.
- Patients with mental retardation or are unable to consent for participation independently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease
The purpose of this study is to evaluate the efficacy of dual intramuscular and intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of patients with moderate to severe peripheral arterial disease in whom amputation was considered the only viable treatment option.
Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive intramuscular and intra-arterial stem cell injections will have improved ankle brachial index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of major limb amputations.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Bone marrow mononuclear cell implantation
- Keywords
- Bone marrow transplantation, Ischemia, Neoangiogenesis, Peripheral arterial disease, Stem cell therapy
- Medical subject headings
- Peripheral Arterial Disease, Ischemia, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow mononuclear cell implantationProcedure or surgery
Dual intramuscular and intra-arterial injections of bone marrow mononuclear cells harvested from the iliac crest. Injection sites are determined by location of stenosis and/or occlusion on angiogram obtained prior to implantation and typically occur in three medial and three lateral sites approximating the disease location.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Implantation | Experimental | Not described Receives: Procedure: Bone marrow mononuclear cell implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major limb amputation
Measured: three months
Secondary outcomes (3)
Improved ABI measurements
Measured: three months
Relief of rest pain
Measured: three months
Ulceration healing
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startDec 2007
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Vascular and Vein Center, Columbus, OH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall W Franz, MD, Principal investigator, The Vascular and Vein Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919516
- Sponsor's protocol ID
- FRANZ-07-0046
- Status last verified
- Dec 2014
- First submitted
- 11 Jun 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Franz RW, Parks A, Shah KJ, Hankins T, Hartman JF, Wright ML. Use of autologous bone marrow mononuclear cell implantation therapy as a limb salvage procedure in patients with severe peripheral arterial disease. J Vasc Surg. 2009 Dec;50(6):1378-90. doi: 10.1016/j.jvs.2009.07.113. Epub 2009 Oct 17.
PubMed 19837539Franz RW, Shah KJ, Pin RH, Hankins T, Hartman JF, Wright ML. Autologous bone marrow mononuclear cell implantation therapy is an effective limb salvage strategy for patients with severe peripheral arterial disease. J Vasc Surg. 2015 Sep;62(3):673-80. doi: 10.1016/j.jvs.2015.02.059.
PubMed 26304481
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00919516
- Acronym / sponsor ID
- FRANZ-07-0046
- Conditions
- Peripheral Arterial Disease
- Keywords
- Bone marrow transplantation, Ischemia, Neoangiogenesis, Peripheral arterial disease, Stem cell therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Vascular and Vein Center, Columbus, OHUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Jun 2009 (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 evaluate the efficacy of dual intramuscular and intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of patients with moderate to severe peripheral arterial disease in whom amputation was considered the only viable treatment option.
Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive intramuscular and intra-arterial stem cell injections will have improved ankle brachial index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of major limb amputations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Implantation | Experimental | Procedure: Bone marrow mononuclear cell implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients at least 18 years of age.
- Patients with moderate or severe limb-threatening PAD, defined as ankle brachial indices (ABI) less than 0.7 or presence of non-healing ischemic ulcers with stenosis or occlusion of two of the following lower extremity arteries: anterior tibial, posterior tibial, and peroneal.
- Patients with conditions that preclude recommendation of traditional endovascular or open bypass treatments.
Key exclusion criteria (5 listed)
- Patients younger than 18 years of age.
- Patients who are eligible to undergo traditional endovascular or open bypass for the treatment of PAD.
- Female patients who are or may be pregnant.
- Patients who are prisoners.
- Patients with mental retardation or are unable to consent for participation independently.
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 |
|---|---|---|
| Bone marrow mononuclear cell implantationDual intramuscular and intra-arterial injections of bone marrow mononuclear cells harvested from the iliac crest. Injection sites are determined by location of stenosis and/or occlusion on angiogram obtained prior to implantation and typically occur in three medial and three lateral sites approximating the disease location. | Procedure or surgery | Stem Cell Implantation |
Primary outcome
Major limb amputation
Time frame: three months
3 secondary outcomes
Improved ABI measurements
Time frame: three months
Relief of rest pain
Time frame: three months
Ulceration healing
Time frame: three months
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 11 Dec 2014.
- Results publication: PubMed 19837539Franz RW, Parks A, Shah KJ, Hankins T, Hartman JF, Wright ML. Use of autologous bone marrow mononuclear cell implantation therapy as a limb salvage procedure in patients with severe peripheral arterial disease. J Vasc Surg. 2009 Dec;50(6):1378-90. doi: 10.1016/j.jvs.2009.07.113. Epub 2009 Oct 17.
- Derived from this study: PubMed 26304481Franz RW, Shah KJ, Pin RH, Hankins T, Hartman JF, Wright ML. Autologous bone marrow mononuclear cell implantation therapy is an effective limb salvage strategy for patients with severe peripheral arterial disease. J Vasc Surg. 2015 Sep;62(3):673-80. doi: 10.1016/j.jvs.2015.02.059.
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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.
Randall W Franz, MD principal investigator
The Vascular and Vein Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow mononuclear cell implantation in people with Peripheral Arterial Disease, run by The Vascular and Vein Center, Columbus, OH at 1 site in United States.
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 5 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 11 Dec 2014. 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 United States. 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.
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?
Major limb amputation (time frame: three months). 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 NCT00919516, which also lists 2 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 11 Dec 2014.