IschemiaPhase 1DANCELL-CLINCT00442143
Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
A Phase 1 study testing Stem cell implantation in people with Ischemia, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Ischemia
- What is being tested?
- Stem cell implantation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Dec 2007
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle blood pressure < 70 mmgHG
- Either pain at rest and/or ischemic wound
- No possible surgical treatment
Who cannot join
- Infection
- Malignant disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of endocrinology M, Odense University Hospital
Odense, 5000
About this study
The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization
Read the detailed description
10 patients with severe lower limb ischemia will be included in this pilote trial.
Bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius.
The patiens are followed for 4 months. Were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.
- Conditions
- Ischemia
- Being tested
- Stem cell implantation
- Keywords
- CLI, PAOD, Severe lower limb ischemia
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell implantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous oxygen pressure
1st toe blood pressure (strain gauge)
Ankle blood pressure
Wound healing
Pain
Secondary outcomes (2)
amputation
Infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startJan 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Moustapha Kassem, MD, Principal investigator, Department of endocrinology M, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442143
- Sponsor's protocol ID
- 024
- Acronym
- DANCELL-CLI
- Status last verified
- Mar 2007
- First submitted
- 28 Feb 2007
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
- ClinicalTrials.gov ID
- NCT00442143
- Acronym / sponsor ID
- DANCELL-CLI / 024
- Conditions
- Ischemia
- Keywords
- CLI, PAOD, Severe lower limb ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 1 Mar 2007 (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 aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization
Detailed description
10 patients with severe lower limb ischemia will be included in this pilote trial.
Bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius.
The patiens are followed for 4 months. Were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ankle blood pressure < 70 mmgHG
- Either pain at rest and/or ischemic wound
- No possible surgical treatment
Key exclusion criteria (2 listed)
- Infection
- Malignant disease
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 |
|---|---|---|
| Stem cell implantation | Procedure or surgery | – |
Primary outcome
Transcutaneous oxygen pressure
1st toe blood pressure (strain gauge)
Ankle blood pressure
Wound healing
Pain
2 secondary outcomes
amputation
Infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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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.
Moustapha Kassem, MD principal investigator
Department of endocrinology M, Odense University Hospital
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 Stem cell implantation in people with Ischemia, run by Odense University Hospital at 1 site in Denmark.
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 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 23 Jul 2010. 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 Denmark. 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 Malthe AM Kristiansen, MD (+4565504081, mkristiansen@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous oxygen pressure. The study lists 5 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 23 Jul 2010.