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

JRCT ID: jRCTb040190118

Registered date:20/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: critical limb ischemia
• Date of first enrollment: 08/06/2016
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 closed centrifugal cell separator system with adipose digesting enzyme product. Isolated ADRCs were diluted with lactated Ringers solution to a total volume of 50 ml and the diluted ADRC solution was injected into the gastrocnemius or hand of the ischemic limb, 0.5-1.0 ml using 23 to 26-gauge needle into 40-60 sites.

Outcome(s)

Primary Outcome

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 Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 25age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Murohara Toyoaki