Bone marrow mononuclear cell implantation for patients with critical limb ischemia

Bone marrow mononuclear cell implantation for patients with critical limb ischemia - BMI study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021422

Enrollment

Registered

2016-03-10

Start date

2016-03-10

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 Arterial Disease (PAD) , Buerger disease, and arteritis associated with collagen diseases (Fontaines stage: III and IV)

Interventions

Under general anesthesia, between 500 and 1,000 ml of bone marrow is collected from each patient. The mononuclear cells are separated to 95% purity and are concentrated to produce a final volume of ab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Peripheral Arterial Disease (PAD) , Buerger disease, and arteritis associated with collagen diseases 1. Fontaines stage: III and IV 2. Patient with critical limb ischemia, who were not candidates for endovascular treatment /surgical revascularisation, or skin perfusion pressure<40mmHg at ischemic leg even after endovascular treatment /surgical revascularisation 4. Age: greater than 20 or less than 80 years

Exclusion criteria

Exclusion criteria: 1. Patients with the expected rest of their life less than 1 year 2. Patients with drug dependence during the past 3 months 3. Patients with malignant evidence of malignant disorder during the past 5 years 4. Patients with poorly controlled diabetes mellitus accompanied with proliferative retinopathy 5. Patients without informed consent 6. Pregnant or possibly pregnant females 7. Patients with acute myocardial infarction, unstable angina, myocarditis, or cerebral infarction during the past 1 month 8. Patients with active infection including Treponema pallidum, or positive test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) 9. Patients with history of allergy for antibiotics 10. Patients with anemia or thrombocytopenia 11. Patients judged inappropriate for this study by phisician 12. Patients without agreement for including in this study

Design outcomes

Primary

Measure	Time frame
improvement of skin perfusion pressure level at ischemic leg 1 month after BMI	—

Countries

Japan

Contacts

Public ContactTakuya Ozawa

Niigata University Graduate School of Medical and Dental Sciences Department of Cardiovascular Biology and Medicine

takuya-o@med.niigata-u.ac.jp0252272185

Outcome results

None listed

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