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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000199 |
Receipt No. | R000000186 |
Scientific Title | Therapeutic angiogenesis for peripheral artery diseases by combination of adrenomedullin and peripheral mononuclear cell transplantation |
Date of disclosure of the study information | 2005/09/13 |
Last modified on | 2011/09/06 |
Basic information | ||
Public title | Therapeutic angiogenesis for peripheral artery diseases by combination of adrenomedullin and peripheral mononuclear cell transplantation | |
Acronym | Therapeutic angiogenseis by combination of adrenomedullin and cell transplantation | |
Scientific Title | Therapeutic angiogenesis for peripheral artery diseases by combination of adrenomedullin and peripheral mononuclear cell transplantation | |
Scientific Title:Acronym | Therapeutic angiogenseis by combination of adrenomedullin and cell transplantation | |
Region |
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Condition | |||
Condition | peripheral artery disease | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety and efficacy of therapeutic angiogenesis for peripheral artery diseases by combination of peripheral mononuclear cell transplantation and adrenomedullin administration. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Adverse events |
Key secondary outcomes | Improvement of pain, skin necrosis, and walking distance |
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 | Transplantation of peripheral mononuclear cells into ischemic limb muscles, followed by administration of adrenomedullin.
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
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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 | 1)Patients with rest pain, non-healing ischemic ulcers, and/or intermittent claudication.
2)Significant stenosis in superficial femoral, popliteal, and/or below knee arteries by DSA, CTA, and/or MRA. 3)Patients who are not candidates for angioplasty or bypass surgery. 4)Written informed consent. |
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Key exclusion criteria | 1)malignant disorder.
2)uncontrolled liver disorder. 3)acute myocardial infarction, unstable angina, myocarditis, cerebral infarction within one month. 4)active infection. 5)pregnancy or child bearing potentials. 6)diabetic retinopathy (untreated proliferative retinopathy). |
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Target sample size | 6 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cardiovascular Center | ||||||
Division name | Department of Organ Transplantation | ||||||
Zip code | |||||||
Address | 5-7-1 Fujishiro-dai, Suita, Osaka | ||||||
TEL | 06-6833-5012 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | National Cardiovascular Center | ||||||
Division name | Cardiology | ||||||
Zip code | |||||||
Address | |||||||
TEL | 06-6833-5012 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | National Cardiovascular Center |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | |
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 | One out of 6 patients exhibited allergic reaction-like symptoms, and wediscontinued administration of the test drug to this patient, afterwards he hadgotten free from those symptoms.
The Safety Committee assessed the causal relationship between theallergic reaction-like symptoms and the test drug, and it was concluded that thepatients was in extremely nervous situation, and this might have influenced tothe occurrence of those symptoms. This trial was completed without any severe adverse events. |
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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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
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=R000000186 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |