Multiple dose regenerative therapy using ex vivo expanded autologous peripheral mononuclear cells (MNC-QQ) for patients with non-healing ischemic hindlimb wound -Phase1/2 Study-

Multiple dose regenerative therapy using ex vivo expanded autologous peripheral mononuclear cells (MNC-QQ) for patients with non-healing ischemic hindlimb wound -Phase1/2 Study- - Multiple dose regenerative therapy using ex vivo expanded autologous peripheral mononuclear cells (MNC-QQ) for patients with non-healing ischemic hindlimb wound -Phase1/2 Study-

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034775

Enrollment

Registered

2018-11-15

Start date

2018-09-26

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

non-healing ischemic hindlimb wound

Interventions

Ex vivo expanded autologous peripheral mononuclear cells, 1x10^7 cells

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with written informed consent. 2. Patients are at the age of 20 to 75 at the time of informed consent. 3. Patients with Atherosclerotic PAD with >70% luminal stenosis in the leg arteries by digital subtraction angiography. 4. Patients who developed chronic hindlimb ischemia more than three months ago before having informed consent. 5. Patients of Rutherford classification, category 5. 6. Patients without adaptation for transluminal angioplasty or stenting and bypath surgery.

Exclusion criteria

Exclusion criteria: 1. Patients of Rutherford classification, category 6. 2. Patients with wound on heel. 3. Patients with Buerger's disease. 4. Patients with treatments of angioplasty, bypath surgery or LDL-apheresis for expecting leg for cell transplantation within a month. 5. Patients with HbA1c more than 8.0 with the medication for diabetes. 6. Patients with severe systemic infection. 7. Patients with severe anemia. 8. Patients with major amputation of another leg. 9. Patients with NYHA3 or 4, or Left ventricular ejection fraction< 25%. 10. Patients who have treatment with anti-angiogenic medicine for proliferative diabetic retinopathy and other disease. 11. Patients have malignancy, or within 5 years after recover from malignant tumor (10 years after breast cancer), except for cutaneous basal cell carcinoma. 12. Patients with hematopoietic disorders such as leukemia, myeloproliferative disease, marrow dysplasia syndrome. 13. Pregnant women, lactating women, female patients who may be pregnant, and who plan the pregnancy by the end of the observation period. 14. Patients infected with HIV, active HBV, HCV, HTLV, or syphilis in screening test. 15. Patients not expecting live for a year or more. 16. Patients enrolled in any other clinical trial within 90 days before informed consent. 17. Any other reason that the Clinical Researchers may have for considering a case unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Efficacy	—

Countries

Japan

Contacts

Public ContactRica Tanaka

Juntendo Univeristy School of Medicine Department of Regenerative Therapy

rtanaka@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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