Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger's disease, collagen disease)

Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger's disease, collagen disease) - Autologous mesenchymal cell implantation in patients with peripheral artery disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013820

Enrollment

Registered

2014-05-01

Start date

2014-05-01

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

Peripheral artery disease (arteriosclerosis obliterans, Buerger&#39

Interventions

Autologous mesenchymal cell implantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) written informed consent 2) >20 years of age 3) rest pain, ulcer or gangrene accompanying by stenosis or occlusion of arteries either superficial femoral artery, popliteal artery or below the knee artery 4) not applicable for endovascular therapy or bypass surgery

Exclusion criteria

Exclusion criteria: 1) having malignancy 2) prior myocardial infarction, unstable angina, myocarditis, cerebrovascular infarction within 2 months 3) activating inflammation 4) possible pregnancy 5) activating proliferative retinopathy

Design outcomes

Primary

Measure	Time frame
1) Safety a) Adverse event, side effect b) Laboratory data 2) Efficacy Primary outcomes (6 months after implantation) Improvement of symptom or physical examination according to Fontaine classification at baseline a) Fontaine IIb: >20% improvement of initial claudication distance or absolute claudication distance b) Fontaine III: >2cm improvement of visual analogue scale c) Fontaine IV: >25% reduction of ulcer size in patients with ulcer or free of major amputation in patients with gangrene	—

Measure

Time frame

1) Safety a) Adverse event, side effect b) Laboratory data 2) Efficacy Primary outcomes (6 months after implantation) Improvement of symptom or physical examination according to Fontaine classification at baseline a) Fontaine IIb: >20% improvement of initial claudication distance or absolute claudication distance b) Fontaine III: >2cm improvement of visual analogue scale c) Fontaine IV: >25% reduction of ulcer size in patients with ulcer or free of major amputation in patients with gangrene

—

Countries

Japan

Contacts

Public ContactHiroshi Suzuki

Showa University Fujigaoka Hospital Deartment of Invernal Medicine, Division of Cardiology

hrsuzuki@med.showa-u.ac.jp045-971-1151

Outcome results

None listed

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

Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger&#39;s disease, collagen disease)