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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002280
Receipt No. R000002791
Scientific Title Randomized controlled trial of G-CSF-mobilized peripheral blood mononuclear cells transplantation for the treatment of patients with Peripheral Arterial Disease
Date of disclosure of the study information 2009/08/01
Last modified on 2018/08/08

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Basic information
Public title Randomized controlled trial of G-CSF-mobilized peripheral blood mononuclear cells transplantation for the treatment of patients with Peripheral Arterial Disease
Acronym IMPACT STUDY
Scientific Title Randomized controlled trial of G-CSF-mobilized peripheral blood mononuclear cells transplantation for the treatment of patients with Peripheral Arterial Disease
Scientific Title:Acronym IMPACT STUDY
Region
Japan

Condition
Condition Peripheral Arterial Disease (arteriosclerosis obliterans, buerger's disease)
Classification by specialty
Cardiology Nephrology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of G-CSF-mobilized peripheral blood mononuclear cells transplantation for the patients with PAD(ASO, Buerger's disease), who are unresponsive to standard therapy, we compare the recommended treatment group, the recommended treatment and cells transplantation group, and the cells transplantation group.
The recommended therapy is performed based on TASC2 and'Guideline 2 diagnosis and treatment for inferior ASO'edited by Japanese college of angiology.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes 1) Changes of Fontaine classification or Rutherford classification
2) Overall survival
3) Time-to-amputation
4) Amputation-free survival
5) Ulcer /Gangrene size
6) Severity of ischemic pain in lower limbs
7) ABI (TBI in measurable patients)
8) ICD and ACD

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Recommended treatment group

The recommended therapy is performed based on TASC2 and 'Guideline 2 diagnosis and treatment for inferior ASO' edited by Japanese college of angiology.
Interventions/Control_2 Recommended treatment and Cells transplantation group
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with ASO or Buerger's disease confirmed obstruction or stenosis by leg angiography
2) Patients whose Fontaine classification is 2-4 and Rutherford classification is 1-5 in either limb.
3) Patients without indication of angioplasty and bypass surgery to arteria poplitea (constricted portion is diffuse or at peripheral micro artery), or uncontrollable the disease by these traditional treatment(No option patients)
4) Nonsmoking for over a month
5) Age is between 20 and 75. Patients who can give informed consent themselves in writing
Key exclusion criteria 1) Patients with severity progression of Fontaine classification or Rutherford classification within 1 month
2) Major amputation of lower limb is planned
3) Patients who performed angioplasty, bypass surgery, other surgical therapy or LDL apheresis within 1 month.
4) Patients who have serious allergic reaction or adverse reaction to G-CSF or apheresis
5) Patients with uncontrolled ischemic heart disease, heart failure or arrhythmia
6) Patients with severe stenotic lesion at major artery in intracranial or extracranial
7) Less than 6 months since last episode of myocardial/brain infarction, brain hemorrhage or TIAs.
8) Dialysis patients of Fontaine4, who have a history of ischemic heart disease, brain infarction or brain hemorrhage.
9) Patients with diabetic proliferating retinopathy (new Fukuda classification BI to BV).
10) Patients with malignant tumor within 3 years
11) Leukocytes less than 4,000/&micro;L or exceeding 10,000/&micro;L., platelets less than 50,000/&micro;L, AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L
12) Patients who have coexisting or history of interstitial pneumonia, or take the medicine with possibility of causing interstitial pneumonia
13) Patients who complicated by infection with fever over 38C
14) Patients with splenomegaly
15) Patients with claudication symptom, rest pain, ulcer or gangrene unrelated to primary disease
16) Patients with severe neuropathy in the lower limbs, and be difficult to evaluate in this trial
17) Patients with uncontrollable mental disorders
18) Patients with coexisting or history of hyperfunction of thyroid gland
19) Patient who is within 6 months from the end of other trails
20) The females who are in pregnancy or lactation, may be pregnant, or are planning to become pregnant before the end of trial period. The males who desire pregnancy of partner.
Target sample size 144

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Horie
Organization Sapporo Hokuyu Hospital
Division name Department of Surgery
Zip code
Address 6-5-1, Higasisapporo 6-Jo,
TEL 011-865-0111
Email saiseichiryo@hokuyu_aoth.org

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Horie
Organization Sapporo Hokuyu Hospital
Division name Department of Surgery
Zip code
Address 6-5-1, Higasisapporo 6-Jo,
TEL 011-865-0111
Homepage URL http://padct.jp/
Email saiseichiryo@hokuyu-aoth.org

Sponsor
Institute Japan Study group of peripheral vascular regeneration cell therapy
Institute
Department

Funding Source
Organization Resarch Foundation for Community Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 TRIPAD0708
Org. issuing International ID_1 TRI
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/82/8/82_CJ-17-1220/_article
Number of participants that the trial has enrolled
Results
Background:The clinical usefulness of peripheral blood (PB) mononuclear cell (MNC) transplantation in patients with peripheral arterial disease (PAD), especially in those with mild-to-moderate severity, has not been fully clarified.
Methods´╝čand´╝čResults:A randomized clinical trial was conducted to evaluate the efficacy and safety of granulocyte colony-stimulating factor (G-CSF)-mobilized PBMNC transplantation in patients with PAD (Fontaine stage 2-3 and Rutherford category 1-5) caused by arteriosclerosis obliterans or Buergers disease. The primary endpoint was progression-free survival (PFS). In total, 107 subjects were enrolled. At baseline, Fontaine stage was 2/3 in 82 patients and 4 in 21, and 54 patients were on hemodialysis. A total of 50 patients had intramuscular transplantation of PBMNC combined with standard of care (SOC) (cell therapy group), and 53 received SOC only (control group). PFS tended to be improved in the cell therapy group than in the control group (P=0.07). PFS in Fontaine stage 2/3 subgroup was significantly better in the cell therapy group than in the control group. Cell therapy-related adverse events were transient and not serious.
Conclusions:In this first randomized, large-scale clinical trial of G-CSF-mobilized PBMNC transplantation, the cell therapy was tolerated by a variety of PAD patients. The PBMNC therapy was significantly effective for inhibiting disease progression in mild-to-moderate PAD.
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 Completed
Date of protocol fixation
2009 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2015 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002791

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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