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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001597 |
Receipt No. | R000001916 |
Scientific Title | Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases |
Date of disclosure of the study information | 2008/12/24 |
Last modified on | 2012/04/17 |
Basic information | ||
Public title | Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases | |
Acronym | Autologous peripheral mononuclear cells transplantation for peripheral arterial diseases | |
Scientific Title | Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases | |
Scientific Title:Acronym | Autologous peripheral mononuclear cells transplantation for peripheral arterial diseases | |
Region |
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Condition | ||
Condition | peripheral arterial diseases | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effect on blood flow following intramuscular administration of peripheral mononuclear cells collected by blood separator in patients with peripheral arterial diseases |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Subjective ischemic symptoms |
Key secondary outcomes | Improvement of arterial blood flow
Neovascularization Time to amputation |
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 |
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Interventions/Control_1 | intramuscular administration of peripheral mononuclear cells collected by blood separator | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with arteriosclerosis obliterans diagnosed as Fontaine's classification III or IV, or patients with Buerger's disease
Patients who were disclosed their arterial disease and agreed with enrollment into the study by document |
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Key exclusion criteria | Patients intolerable for extracorporeal circulation
Congestive heart failure (ejection fraction <50%) Renal failure (serum creatinine < 1.6 mg/dL) Women on (possible) pregnancy or lactation Patients judged inadequate by doctor in charge of the patient or the study |
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Target sample size | 5 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Hospital Organization Awara Hospital | ||||||
Division name | Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 238-1 Kitagata, Awara, Fukui 910-4272, Japan | ||||||
TEL | 0776-79-1211 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | National Hospital Organization Awara Hospital | ||||||
Division name | Department of Pharmacy | ||||||
Zip code | |||||||
Address | 238-1 Kitagata, Awara, Fukui 910-4272, Japan | ||||||
TEL | 0776-79-1211 | ||||||
Homepage URL | http://www.hosp.go.jp/~awara/kenkyu.html | ||||||
nhoawara-secretary@umin.ac.jp |
Sponsor | |
Institute | National Hospital Organization Awara Hospital |
Institute | |
Department |
Funding Source | |
Organization | National Hospital Organization Awara Hospital |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001916 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |