Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease

Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease - Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009943

Enrollment

Registered

2013-12-01

Start date

2014-01-21

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 (Fontaine stages three and four)

Interventions

Bone marrow of about 20ml is taken from the patient. The bone marrow is transferred to National Institute of Advanced Industrial Science and Technology (AIST) at Amagasaki city and cultured to expand

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Peripheral Artery Disease: PAD (2) Fontaine stages III and IV (ABI less than 0.6) (3) The patient showing contraindications of angioplasty and bypass surgery due to spread areas of stricture or the stricture in small peripheral artery. Patients already treated with such angioplasty and bypass surgery, but showing the symptoms corresponding to above category (2). (4) The patients by whom written consent is got from himself/herself by aged 20 and over (at the time of consent acquisition).

Exclusion criteria

Exclusion criteria: (1) The patient of hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, and adult T-cell leukemia (2) The hypersensitivity to a cow or pig origin protein, the patient that has the past of side effects (3) The patient showing severe cardiac failure evidenced by cardiac echo examination. (4) Malignant diseases. (5) High-risk retinopathy (6) Serious problems of liver and renal function (7) Interstitial pneumonia. (8) Blood diseases such as anemia and leykocytosis. (9) A pregnant woman, a nursing mother, the patient that may have become pregnant, the female patient who is planning pregnancy by the end of this treatment term. (10) In addition, the patient whom the principal investigator or the researcher judged to be unsuitable based on the medical rationale

Design outcomes

Primary

Measure	Time frame
ABI(Ankle Brechial Pressure Index): 7days, 1,6 and 12 months post transplantation. Angiography : 12 months post transplantation.	—

Secondary

Measure	Time frame
Walking time without pain using tredmil: 1, 6 and 12 months post transplantation	—

Countries

Japan

Contacts

Public ContactHiroaki Narita

Rogenkai Welfare Group Headquarters

narita@ookuma.or.jp06+64158590

Outcome results

None listed

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