Peripheral Arterial DiseasePhase 1NCT00411840
Novel Therapy of PAD by Combined Transplantation of BMCs
A Phase 1 study testing intraarterial and intramuscular injection of BMCs in people with Peripheral Arterial Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
We analyze the effects of combined intramuscular and intraarterial transplantation of BMCs in patients with PAD. BMCs were transplanted into the ischemic limb. After 2 and 13 months walking distance and perfusion indices were monitored. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- intraarterial and intramuscular injection of BMCs
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- severe limb ischemia
Who cannot join
- infectious disease
- cancer
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heinrich-Heine-University
Düsseldorf, 40225
Bodo E Strauer, MD, +492118118801, strauer@med.uni-duesseldorf.de
Thomas Bartsch, MD
About this study
Official title: Transplantation of Autologous Mononuclear Bone Marrow Stem Cells in Patients With Peripheral Arterial Disease (TAM-PAD Study)
We analyze the effects of combined intramuscular and intraarterial transplantation of BMCs in patients with PAD. BMCs were transplanted into the ischemic limb.
After 2 and 13 months walking distance and perfusion indices were monitored.
- Conditions
- Peripheral Arterial Disease
- Being tested
- intraarterial and intramuscular injection of BMCs
- Keywords
- stem cell therapy, peripheral arterial disease, limb ischemia
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarterial and intramuscular injection of BMCsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography
Secondary outcomes (1)
feasibility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Investigators
- Bodo E Strauer, MD, Study director, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411840
- Sponsor's protocol ID
- TAM-PAD
- Status last verified
- Dec 2006
- First submitted
- 13 Dec 2006
- Last updated
- 15 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Autologous Mononuclear Bone Marrow Stem Cells in Patients With Peripheral Arterial Disease (TAM-PAD Study)
- ClinicalTrials.gov ID
- NCT00411840
- Acronym / sponsor ID
- TAM-PAD
- Conditions
- Peripheral Arterial Disease
- Keywords
- stem cell therapy, peripheral arterial disease, limb ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jul 2004
- First posted
- 15 Dec 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.
We analyze the effects of combined intramuscular and intraarterial transplantation of BMCs in patients with PAD. BMCs were transplanted into the ischemic limb.
After 2 and 13 months walking distance and perfusion indices were monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- severe limb ischemia
Key exclusion criteria (2 listed)
- infectious disease
- 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 |
|---|---|---|
| intraarterial and intramuscular injection of BMCs | Procedure or surgery | – |
Primary outcome
ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography
1 secondary outcome
feasibility
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2006.
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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.
Bodo E Strauer, MD study director
Heinrich-Heine University, Duesseldorf
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 intraarterial and intramuscular injection of BMCs in people with Peripheral Arterial Disease, run by Heinrich-Heine University, Duesseldorf 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 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 15 Dec 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 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. 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 Thomas Bartsch, MD (+492118118800, bartsch@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography. 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 15 Dec 2006.