UMIN-CTR Clinical Trial

Basic information
Public title	G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia.
Acronym	CD34+ cell transplantation for patients with CLI.
Scientific Title	G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia.
Scientific Title:Acronym	CD34+ cell transplantation for patients with CLI.
Region	Japan

Condition
Condition	Critical limb ischemia in patients undergoing hemodialysis
Classification by specialty	Cardiology Nephrology Vascular surgery Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of safety and efficacy of G-CSF mobilized autologous peripheral blood derived CD34+ cell transplantation in hemodialysis patients with critical limb ischemia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety and efficacy evaluation of the therapy for 52 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Intra-muscular injection of G-CSF mobilized autologous peripheral blood derived CD34+ cell
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shuzo Middle name Last name KOBAYASHI
Organization	Shonan Kamakura General Hospital
Division name	Kidney Disease and Transplant Center
Zip code	247-8533
Address	1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
TEL	0467-46-1717
Email	shuzo@shonankamakura.or.jp

Public contact
Name of contact person	1st name Takayasu Middle name Last name OHTAKE
Organization	Shonan Kamakura General Hospital
Division name	Kidney Disease and Transplant Center
Zip code	247-8533
Address	1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
TEL	0467-46-1717
Homepage URL
Email	ohtake@shonankamakura.or.jp

Sponsor
Institute	Center for Clinical and Translational Science, Shonan Kamakura General Hospital, Tokushukai Medical Group.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Certified Committee of Shonan Kamakura General Hospital for Regenerative Medicine
Address	1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
Tel	0467-46-1717
Email	rm_committee@shonankamakura.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 16 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 05 Month 10 Day
Date of IRB	2019 Year 01 Month 21 Day
Anticipated trial start date	2019 Year 07 Month 16 Day
Last follow-up date	2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Please refer to the information in jRCT (jRCTb030190142) on and after November 27, 2019.

Management information
Registered date	2019 Year 07 Month 11 Day
Last modified on	2020 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042515