TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

NCT00145262 | Unknown

• 1 other identifier: 66
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

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

Interventions

Autologous Bone Marrow Mononuclear Cell Implantation PROCEDURE

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nagoya University: lead

Study Sites (1)

Department of Cardiology, Nagoya University Graduate School of Medicine

Nagoya, 466-8550, Japan

RECRUITING

Related Publications (2)

• 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.

  PMID: 12241713 BACKGROUND

• 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.

  PMID: 17251666 DERIVED

MeSH Terms

Conditions

Thromboangiitis Obliterans; Arteriosclerosis Obliterans; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Arteriosclerosis; Peripheral Arterial Disease; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Toyoaki Murohara, MD, PhD

  Department of Cardiology, Nagoya University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murohara Toyoaki

CONTACT

81-52-744-2149; murohara@med.nagoya-u.ac.jp

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: August 1, 2003
• Last Updated: December 30, 2005

Record last verified: 2003-08

Locations

JP (1)