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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000031645 |
Receipt No. | R000036129 |
Scientific Title | Clinical trial related with transplantation therapy with human autologous cell mixed sheets for refractory cutaneous ulcer |
Date of disclosure of the study information | 2018/03/09 |
Last modified on | 2018/03/09 |
Basic information | ||
Public title | Clinical trial related with transplantation therapy with human autologous cell mixed sheets for refractory cutaneous ulcer | |
Acronym | Autologous cell mixed sheets transplantation for refractory cutaneous ulcer | |
Scientific Title | Clinical trial related with transplantation therapy with human autologous cell mixed sheets for refractory cutaneous ulcer | |
Scientific Title:Acronym | Autologous cell mixed sheets transplantation for refractory cutaneous ulcer | |
Region |
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Condition | ||
Condition | refractory cutaneous ulcer | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify safety of transplantation therapy with human autologous cell mixed cell sheet which consist of fibroblasts and peripheral blood mononuclear cells for patients with refractory cutaneous ulcer |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Presence or absence, frequency, and severity of all adverse events |
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 |
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Interventions/Control_1 | Therapeutic angiogenesis using autologous bone marrow mononuclear 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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Patients not adequate for conventional therapy.
2. Patients with wound area of cutaneous ulcers which is covered with cell sheets enough. 3. Patients can provide written informed consent for study participation. 4. Patients with venous reflux detected by air plethysmography or ultrasound. |
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Key exclusion criteria | 1. Patients suffering from critical limb ischemia.
2. Patients suffering from malignant neoplasm. 3. Patients suffering from bacterial infections such as treponema palladium, chlamydia, gonorrhea and tuberculosis. 4. Patients suffering from infections such as hepatitis B and C viruses, human immunodeficiency virus, human T lymphotropic virus type 1 and parvovirus B19. 5. Patients with allergy of local anesthesia. 6. Hemoglobin: < 8.0 g/dL, Plt: < 50,000 /uL, Prothrombin time: < 40% 7. Patients with sepsis or suspected with. 8. Patients with congenital coagulopathy, antiplatelet drug use, or anticoagulant use. 9. Patients who have experienced other cell or gene therapy 10. Patients who join other clinical trials or joined them within 6 months. 11. Patients with hemodialysis. 12. Patients who developed unstable angina, myocardial ischemia, or cerebral infarction within 3 months 13. Pregnant woman and women who may possibly be pregnant, women in nursing 14. Patients with allergy of aminoglycoside antibiotics. 15. Patient determined to be ineligible for this clinical study by research attending physician. |
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Target sample size | 6 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine | ||||||
Division name | Division of first surgery | ||||||
Zip code | |||||||
Address | Ube, 755-8505, Japan | ||||||
TEL | 0836-22-2261 | ||||||
tmizo@yamaguchi-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine | ||||||
Division name | Division of first surgery | ||||||
Zip code | |||||||
Address | Ube, 755-8505, Japan | ||||||
TEL | 0836-22-2261 | ||||||
Homepage URL | |||||||
tmizo@yamaguchi-u.ac.jp |
Sponsor | |
Institute | Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine |
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 | |
Address | |
Tel | |
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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
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=R000036129 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |