Unique ID issued by UMIN | C000000199 |
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Receipt number | 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 16:11:05 |
Therapeutic angiogenesis for peripheral artery diseases by combination of adrenomedullin and peripheral mononuclear cell transplantation
Therapeutic angiogenseis by combination of adrenomedullin and cell transplantation
Therapeutic angiogenesis for peripheral artery diseases by combination of adrenomedullin and peripheral mononuclear cell transplantation
Therapeutic angiogenseis by combination of adrenomedullin and cell transplantation
Japan |
peripheral artery disease
Cardiology | Vascular surgery |
Others
NO
To evaluate the safety and efficacy of therapeutic angiogenesis for peripheral artery diseases by combination of peripheral mononuclear cell transplantation and adrenomedullin administration.
Safety,Efficacy
Adverse events
Improvement of pain, skin necrosis, and walking distance
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Transplantation of peripheral mononuclear cells into ischemic limb muscles, followed by administration of adrenomedullin.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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).
6
1st name | |
Middle name | |
Last name | Takeshi Nakatani |
National Cardiovascular Center
Department of Organ Transplantation
5-7-1 Fujishiro-dai, Suita, Osaka
06-6833-5012
1st name | |
Middle name | |
Last name | Satoshi Takeshita |
National Cardiovascular Center
Cardiology
06-6833-5012
National Cardiovascular Center
Ministry of Health, Labour and Welfare
Japan
NO
2005 | Year | 09 | Month | 13 | Day |
Unpublished
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.
Completed
2004 | Year | 08 | Month | 01 | Day |
2004 | Year | 08 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2005 | Year | 09 | Month | 13 | Day |
2011 | Year | 09 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000186
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