Related Experiment Video
Updated: Sep 5, 2025
Isolation of Adipose Derived Regenerative Cells for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
Published on: December 28, 2021
Therapeutic angiogenesis for patients with no-option critical limb ischemia by adipose-derived regenerative cells:
Yuuki Shimizu1, Kazuhisa Kondo2, Ryo Hayashida2
1Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya, 466-8550, Japan. shimi123@med.nagoya-u.ac.jp.
Insights
Adipose-derived regenerative cells (ADRCs) transplantation is safe and effective for critical limb ischemia (CLI) patients, showing high survival and limb salvage rates. This cell therapy promotes therapeutic angiogenesis, improving quality of life and healing outcomes.
Area of Science:
- Regenerative Medicine
- Vascular Biology
- Cell Therapy
Background:
- Critical limb ischemia (CLI) presents a significant risk of lower limb amputation, impacting patient quality of life and prognosis.
- Adipose-derived regenerative cells (ADRCs) possess angiogenic potential, offering a promising therapeutic avenue for limb ischemia.
Purpose of the Study:
- To investigate the safety, feasibility, and efficacy of therapeutic angiogenesis by cell transplantation (TACT) of ADRCs in patients with CLI.
- To evaluate ADRC implantation as a treatment option for patients with CLI who have exhausted conventional therapies.
Main Methods:
- A prospective, interventional, open-label, multicenter clinical trial (TACT-ADRC) was conducted in Japan.
- Freshly isolated autologous ADRCs were implanted into 34 ischemic limbs of 29 patients with CLI (Fontaine class III-IV) ineligible for standard revascularization.
- The study focused on safety, overall survival, and limb salvage as primary endpoints.
Main Results:
- 100% overall survival rate was observed at post-operative and 6-month follow-up.
- 94.1% of treated limbs (32/34) were free from major amputation at 6 months.
- Significant improvements were noted in quality of life scores (90.6%), ulcer size reduction (83.3%), and 6-minute walking distance (72.2%).
Conclusions:
- Autologous ADRC implantation is a safe and effective treatment for critical limb ischemia, achieving therapeutic angiogenesis.
- The procedure demonstrated an optimal survival rate and high limb salvage in patients lacking conventional treatment options.
- The TACT-ADRC trial provides evidence for ADRCs as a viable therapeutic strategy in multicenter settings.
Background:
Patients with critical limb ischemia (CLI) still have a high rate of lower limb amputation, which is associated with not only a decrease in quality of life but also poor life prognosis. Implantation of adipose-derived regenerative cells (ADRCs) has an angiogenic potential for patients with limb ischemia.
Objectives:
We investigated safety, feasibility, and efficacy of therapeutic angiogenesis by cell transplantation (TACT) of ADRCs for those patients in multicenter clinical trial in Japan.
Methods:
The TACT-ADRC multicenter trial is a prospective, interventional, open-labeled study. Patients with CLI (Fontaine class III-IV) who have no other option for standard revascularization therapy were enrolled in this study. Thirty-four target ischemic limbs of 29 patients were received freshly isolated autologous ADRCs implantation.
Results:
The overall survival rate at a post-operative period and at 6 months follow-up was 100% at any time points. As a primary endpoint for efficacy evaluation, 32 limbs out of 34 (94.1%) were free from major amputation for 6 months. Numerical rating scale (from 6 to 1) as QOL score, ulcer size (from 317 mm2 at to 109 mm2), and 6-min walking distance (from 255 to 369 m) improved in 90.6%, 83.3%, and 72.2% patients, respectively.
Conclusions:
Implantation of autologous ADRCs could be safe and effective for the achievement of therapeutic angiogenesis in the multicenter settings, as a result in no major adverse event, optimal survival rate, and limb salvage for patients with no-conventional option against critical limb ischemia. TRN: jRCTb040190118; Date: Nov. 24th, 2015.
