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TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

NCT ID: NCT00145262

Last Updated: 2005-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Buerger Disease Arteriosclerosis Obliterans

Keywords

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critical limb ischemia bone marrow mononuclear cells angiogenesis vasculogenesis Arteriosclerosis Obliterans (ASO) Ischemic ulcers

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Autologous Bone Marrow Mononuclear Cell Implantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagoya University

OTHER

Sponsor Role lead

Principal Investigators

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Toyoaki Murohara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Nagoya University Graduate School of Medicine

Locations

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Department of Cardiology, Nagoya University Graduate School of Medicine

Nagoya, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Murohara Toyoaki

Role: CONTACT

Phone: 81-52-744-2149

Email: [email protected]

Facility Contacts

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Toyoaki Murohara, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 12241713 (View on PubMed)

Kajiguchi 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.

Reference Type DERIVED
PMID: 17251666 (View on PubMed)

Other Identifiers

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66

Identifier Type: -

Identifier Source: org_study_id