Buerger DiseaseNCT00145262
TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation
An observational study of Buerger Disease and Arteriosclerosis Obliterans, run by Nagoya University at 1 site in Japan.
Trial summary
Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Buerger Disease, Arteriosclerosis Obliterans
- What is being tested?
- Autologous Bone Marrow Mononuclear Cell Implantation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Aug 2003to not given
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have chronic limb ischemia, including rest pain, non-healing ischemic ulcers, or both, and who are not candidates for nonsurgical or surgical revascularisation.
Who cannot join
- Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 6.5% and proliferative retinopathy)
- Evidence of malignant disorder during the past 5 years
- Subjects who cannot survive more than 1 year with other complications
- Malignant rheumatic arthritis
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Cardiology, Nagoya University Graduate School of Medicine
Nagoya, 466-8550
Toyoaki Murohara, MD, PhD, 81-52-744-2149, murohara@med.nagoya-u.ac.jp
About this study
Official title: Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya
Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation. We, the investigators at Nagoya University, further investigated the efficacy and safety of autologous implantation of BM-MNCs or PB-MNCs in patients with severe ischaemic limbs who have no other alternative therapeutic options. We also examined a potential limiting factor which reduced the efficacy of therapeutic angiogenesis using cell transplantation (TACT).
- Conditions
- Buerger Disease, Arteriosclerosis Obliterans
- Being tested
- Autologous Bone Marrow Mononuclear Cell Implantation
- Keywords
- critical limb ischemia, bone marrow mononuclear cells, angiogenesis, vasculogenesis, Arteriosclerosis Obliterans (ASO), Ischemic ulcers
- Medical subject headings
- Thromboangiitis Obliterans, Arteriosclerosis Obliterans, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone Marrow Mononuclear Cell ImplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startAug 2003
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 Buerger 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Investigators
- Toyoaki Murohara, MD, PhD, Principal investigator, Department of Cardiology, Nagoya University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145262
- Sponsor's protocol ID
- 66
- Status last verified
- Aug 2003
- First submitted
- 2 Sep 2005
- Last updated
- 30 Dec 2005
- Results posted
- No
Publications
Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
PubMed 12241713Kajiguchi M, Kondo T, Izawa H, Kobayashi M, Yamamoto K, Shintani S, Numaguchi Y, Naoe T, Takamatsu J, Komori K, Murohara T. Safety and efficacy of autologous progenitor cell transplantation for therapeutic angiogenesis in patients with critical limb ischemia. Circ J. 2007 Feb;71(2):196-201. doi: 10.1253/circj.71.196.
PubMed 17251666
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya
- ClinicalTrials.gov ID
- NCT00145262
- Acronym / sponsor ID
- 66
- Conditions
- Buerger Disease, Arteriosclerosis Obliterans
- Keywords
- critical limb ischemia, bone marrow mononuclear cells, angiogenesis, vasculogenesis, Arteriosclerosis Obliterans (ASO), Ischemic ulcers
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Aug 2003
- First posted
- 5 Sep 2005 (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.
Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation. We, the investigators at Nagoya University, further investigated the efficacy and safety of autologous implantation of BM-MNCs or PB-MNCs in patients with severe ischaemic limbs who have no other alternative therapeutic options. We also examined a potential limiting factor which reduced the efficacy of therapeutic angiogenesis using cell transplantation (TACT).
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who have chronic limb ischemia, including rest pain, non-healing ischemic ulcers, or both, and who are not candidates for nonsurgical or surgical revascularisation.
Key exclusion criteria (4 listed)
- Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 6.5% and proliferative retinopathy)
- Evidence of malignant disorder during the past 5 years
- Subjects who cannot survive more than 1 year with other complications
- Malignant rheumatic arthritis
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 Mononuclear Cell Implantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2005.
- Background: PubMed 12241713Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
- Derived from this study: PubMed 17251666Kajiguchi M, Kondo T, Izawa H, Kobayashi M, Yamamoto K, Shintani S, Numaguchi Y, Naoe T, Takamatsu J, Komori K, Murohara T. Safety and efficacy of autologous progenitor cell transplantation for therapeutic angiogenesis in patients with critical limb ischemia. Circ J. 2007 Feb;71(2):196-201. doi: 10.1253/circj.71.196.
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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.
Toyoaki Murohara, MD, PhD principal investigator
Department of Cardiology, Nagoya University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Buerger Disease and Arteriosclerosis Obliterans, run by Nagoya University at 1 site in Japan.
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 4 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 30 Dec 2005. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murohara Toyoaki (81-52-744-2149, murohara@med.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00145262, 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 30 Dec 2005; AzTrials last refreshed its copy on 6 Nov 2026.