G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia.

G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia. - CD34+ cell transplantation for patients with CLI.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037339

Enrollment

Registered

2019-07-16

Start date

2019-07-16

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

Critical limb ischemia in patients undergoing hemodialysis

Interventions

Intra-muscular injection of G-CSF mobilized autologous peripheral blood derived CD34+ cell

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Atherosclerotic peripheral arterial disease with greater than or equal to 70% luminal stenosis or obstruction in the leg arteries by digital subtraction angiography 2) Undergoing hemodialysis 3) More than 12 weeks since the onset of lower limb ischemia 4) Rutherford category of 4-5 5) Failure of or no indication for transluminal angioplasty/stenting and bypass surgery

Exclusion criteria

Exclusion criteria: 1) Rutherford category of 6 2) Buerger's disease 3) Within 4 weeks after revascularization therapy (bypass surgery or endovascular therapy) or low-density lipoprotein apheresis 4) Severely decreased cardiac function (under 25% of left ventricular ejection fraction on cardiac ultrasonography) 5) Allergic reaction or adverse reaction to G-CSF, the other reagents, or apheresis 6) Malignancy or history of malignancy within past 5 years 7) Advanced diabetic retinopathy 8) Within 12 weeks after myocardial infarction, unstable angina pectoris, or stroke 9) Hematologic disease (leukemia, myeloproliferative disorders, myelodysplastic syndromes, or sickle cell disease) 10) Autoimmune disorders 11) Liver cirrhosis 12) Interstitial pneumonitis or history 13) At least one laboratory abnormality (white blood cell count, under 3,000 /micro L or greater than 15,000/micro L; hemoglobin concentration, under 8 g/dL; platelet count, under 100,000/micro L; aspartate aminotransferase or alanine aminotransferase, equal or greater than 100 IU/L; and serum albumin, under 2 g/dL) 14) Splenomegaly on computed tomography 15) Pregnancy

Design outcomes

Primary

Measure	Time frame
Safety and efficacy evaluation of the therapy for 52 weeks	—

Countries

Japan

Contacts

Public ContactTakayasu OHTAKE

Shonan Kamakura General Hospital Kidney Disease and Transplant Center

ohtake@shonankamakura.or.jp0467-46-1717

Outcome results

None listed

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