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

Not Applicable

• Conditions: critical limb ischemia

• Registration Number: JPRN-jRCTb040190118
• Lead Sponsor: Murohara Toyoaki

Brief Summary

The results of this multicenter clinical trial demonstrate the safety, feasibility, and efficacy of transplanting autologous adipose tissue-derived mesenchymal stem cell progenitor cells for the purpose of antiangiogenic therapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Study Completion: 2020-11-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Target disease: PAD, TAO, and Collagen disease-associated vasculitis

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br> 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 Measures

Name	Time	Method
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.