NCT00145262UnknownNot Applicable
Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Nagoya University
- Locations
- 1
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Defined Population
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Study Sites (1)
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