Therapeutic angiogenesis by cell transplantation with adipose-derived regenerative cells for critical limb ischemia

Therapeutic angiogenesis by cell transplantation with adipose-derived regenerative cells for critical limb ischemia - TACT-ADRC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb040190118

Enrollment

Registered

2020-02-20

Start date

2016-06-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

critical limb ischemia

Interventions

Under general anesthesia, adipose tissue was obtained by liposuction from the subcutaneous abdominal and/or femoral sections. Concentrated ADRCs (5 ml) were isolated using a commercially available clo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Target disease: PAD, TAO, and Collagen disease-associated vasculitis Inclusion criteria: Patients with (1) 25<= Age <80 (2) CLI (Fontaine III-IV), who are not candidates for conventional therapies any more, including surgical revascularization (3) informed consent

Exclusion criteria

Exclusion criteria: Patients with (1) Insufficient amount of adipose tissue (2) No informed consent (3) Expectation of life < 1 year (4) A past 5 years or current history of malignant disease (5) Untreated coronary heart disease or cerebrovascular diseases (6) Untreated diabetic retinopathy (7) Laboratory signs of chronic or acute inflammation (8) Severe liver or kidney dysfunction (9) Severe anemia or pancytopenia (10) Pregnancy (11) Others

Design outcomes

Primary

Measure	Time frame
The safety of the therapy was assessed as a survival rate, the onset of adverse events, malignant neoplasm, and the time course of proliferative retinopathy and arthritis during the 6-month follow-up period after the TACT-ADRC procedure. The amputation-free survival ratio during the 6-month follow-up period after the TACT-ADRC procedure was also assessed as the efficacy of the therapy.	—

Secondary

Measure	Time frame
The secondary endpoints were evaluated by ulcer size (grand total of the longer axis times minor axis), the changes in rest pain using the numerical rating scale (NRS), ABI (ankle biracial index) and skin perfusion pressure (SPP), circulating EPC and cytokines (ex, SDF-1, VEGF, bFGF, HGF) and walking distance in 6 min in patients with lower limb lesions.	—

Countries

Japan

Contacts

Public ContactHironobu Takahashi

Nagoya University School of Medicine

ethics@med.nagoya-u.ac.jp+81-52-744-2479

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026