Arterial Occlusive DiseasesPhase 2NCT00282646
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
A Phase 2 study testing intraarterial stem cell therapy and Stem cells in people with Arterial Occlusive Diseases, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- intraarterial stem cell therapy and Stem cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Mar 2011
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PAOD (Stage III or IV)
- Distal arterial occlusions
- Patients with Buergers Disease
- Signed informed consent
Who cannot join
- Successful bypass operation or intervention within the last 3 months
- Active infection, feber, chronic inflammatory disease
- HIV, Hepatitis
- Tumor within the last 5 years, complete remission required
- Stroke or myocardial infarction within last 3 months
- Renal insufficiency (creatinine > 2 mg/dl)
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- Liver disease (GOT > 2x upper limit oder spontaneous INR > 1,5).
- Anemia (hemoglobin < <10 mg/dl)
- Thrombocytopenia < 100.000/µl
- Allergies to Aspirin, Clopidogrel, Heparin
- Bleeding disorder
- Gastrointestinal bleeding within last 3 months
- Surgery or trauma within the last 2 months
- Pregnancy
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)
Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.
Read the detailed description
Main goal:
Improvement of limb perfusion (Ankle brachial index).
Secondary aims:
Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation (TCO2) Minor or major amputation
- Conditions
- Arterial Occlusive Diseases
- Being tested
- intraarterial stem cell therapy, Stem cells
- Keywords
- critical limb ischemia, peripheral arterial occlusive disease, [C14.907.137]
- Medical subject headings
- Arterial Occlusive Diseases, Chronic Limb-Threatening Ischemia, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarterial stem cell therapyProcedure or surgery
catheter delivery of stem cells
Stem cellsOther
intraarterial application of bone marrow mononuclear cells versus placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | intraarterial application of bone marrow mononuclear cells Receives: Procedure: intraarterial stem cell therapy; Other: Stem cells |
| 2 | Placebo comparator | intraarterial application of placebo Receives: Procedure: intraarterial stem cell therapy; Other: Stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle brachial index
Measured: 6 months
Secondary outcomes (4)
Ulcer size
Measured: 6 months
Pain
Measured: 6 months
Walking distance
Measured: 6 months
TCO2
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 posted27 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionOct 2010
- Study completionMar 2011
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 Arterial Occlusive 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intraarterial administration of BM-MNC or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. M. Zeiher, Johann Wolfgang Goethe University Hospital
- Investigators
- Andreas M Zeiher, MD, Principal investigator, Div. of Cardiology, University of Frankfurt, GermanyDirk H Walter, MD, Study director, Div. of Cardiology, University of Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282646
- Sponsor's protocol ID
- 2005-000968-33
- Other IDs
- PROVASA, 2005
- Status last verified
- Oct 2021
- First submitted
- 25 Jan 2006
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17.
PubMed 21586692Walter DH, Krankenberg H, Balzer JO, Kalka C, Baumgartner I, Schluter M, Tonn T, Seeger F, Dimmeler S, Lindhoff-Last E, Zeiher AM; PROVASA Investigators. Intraarterial administration of bone marrow mononuclear cells in patients with critical limb ischemia: a randomized-start, placebo-controlled pilot trial (PROVASA). Circ Cardiovasc Interv. 2011 Feb 1;4(1):26-37. doi: 10.1161/CIRCINTERVENTIONS.110.958348. Epub 2011 Jan 4.
PubMed 21205939
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)
- ClinicalTrials.gov ID
- NCT00282646
- Acronym / sponsor ID
- 2005-000968-33
- Conditions
- Arterial Occlusive Diseases
- Keywords
- critical limb ischemia, peripheral arterial occlusive disease, [C14.907.137]
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Jan 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.
Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.
Detailed description
Main goal:
Improvement of limb perfusion (Ankle brachial index).
Secondary aims:
Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation (TCO2) Minor or major amputation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Intraarterial administration of BM-MNC or placebo
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: intraarterial stem cell therapy, Other: Stem cellsintraarterial application of bone marrow mononuclear cells |
| 2 | Placebo comparator | Procedure: intraarterial stem cell therapy, Other: Stem cellsintraarterial application of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with PAOD (Stage III or IV)
- Distal arterial occlusions
- Patients with Buergers Disease
- Signed informed consent
Key exclusion criteria (15 listed)
- Successful bypass operation or intervention within the last 3 months
- Active infection, feber, chronic inflammatory disease
- HIV, Hepatitis
- Tumor within the last 5 years, complete remission required
- Stroke or myocardial infarction within last 3 months
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 |
|---|---|---|
| intraarterial stem cell therapycatheter delivery of stem cells | Procedure or surgery | 1, 2 |
| Stem cellsintraarterial application of bone marrow mononuclear cells versus placebo | Other | 1, 2 |
Primary outcome
Ankle brachial index
Time frame: 6 months
4 secondary outcomes
Ulcer size
Time frame: 6 months
Pain
Time frame: 6 months
Walking distance
Time frame: 6 months
TCO2
Time frame: 6 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 26 Oct 2021.
- Derived from this study: PubMed 21586692Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17.
- Derived from this study: PubMed 21205939Walter DH, Krankenberg H, Balzer JO, Kalka C, Baumgartner I, Schluter M, Tonn T, Seeger F, Dimmeler S, Lindhoff-Last E, Zeiher AM; PROVASA Investigators. Intraarterial administration of bone marrow mononuclear cells in patients with critical limb ischemia: a randomized-start, placebo-controlled pilot trial (PROVASA). Circ Cardiovasc Interv. 2011 Feb 1;4(1):26-37. doi: 10.1161/CIRCINTERVENTIONS.110.958348. Epub 2011 Jan 4.
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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.
Andreas M Zeiher, MD principal investigator
Div. of Cardiology, University of Frankfurt, Germany
Dirk H Walter, MD study director
Div. of Cardiology, University of Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intraarterial stem cell therapy and Stem cells in people with Arterial Occlusive Diseases, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 15 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 26 Oct 2021. 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 Germany. 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. Some participants in this study may receive a placebo. 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 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?
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?
Ankle brachial index (time frame: 6 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 NCT00282646, 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 26 Oct 2021.