UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024255 |
|---|---|
| Receipt number | R000027802 |
| Scientific Title | Vascular regeneration therapy using autologous peripheral blood mononuclear cells for refractory skin ulcer associated with connective tissue diseases and vasculitis |
| Date of disclosure of the study information | 2016/11/23 |
| Last modified on | 2022/10/06 17:27:40 |
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Basic information
Public title
Vascular regeneration therapy using autologous peripheral blood mononuclear cells for refractory skin ulcer associated with connective tissue diseases and vasculitis
Acronym
PBMC transplantation for ulcer associated with connective tissue diseases and vasculitis
Scientific Title
Vascular regeneration therapy using autologous peripheral blood mononuclear cells for refractory skin ulcer associated with connective tissue diseases and vasculitis
Scientific Title:Acronym
PBMC transplantation for ulcer associated with connective tissue diseases and vasculitis
Region
| Japan |
Condition
Condition
Patients with refractory skin ulcers resistant to normal treatment, mainly caused by connective tissue diseases and vasculitis
Classification by specialty
| Cardiology | Clinical immunology | Dermatology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the effectiveness and safety of peripheral blood mononuclear cell transplantation for patients with refractory skin ulcer accompanying connective tissue diseases and vasculitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Improvement of skin perfusion pressure at 6 weeks after initial administration
Key secondary outcomes
1. reduction effect of skin ulcer area (long diameter times short diameter, mm) 6 weeks after the first dose
2. improvement degree of pain evaluation (Visual Analogue Scale for pain) 6 weeks after the first dose
3. SPP, 4. transition of ulcer area, 5. change of pain evaluation at each observation point (2, 6, 12, 24, 52 weeks)
6. period until completion of epithelialization
7. questionnaire of QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The concentrated solution of the patients' mononuclear cells administered to the affected limb with ulcer lesions by intramuscular injection. Repeat again the same treatment after two weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with intractable cutaneous ulcers that mainly caused connective tissue diseases and vasculitis
2) Patients who sustained ulcer 3 months or more, or has significantly been QOL failure, or expected amputation
3) over 20 years old
4) patient who can take a informed consent
Key exclusion criteria
1) Patients whose have severe hypersensitivity or history of side effects to aphaeresis
2) Patients whose have malignant tumor or history of malignancy within the past 5 year
3) Patients whose have suffering acute myocardial infarction, unstable angina pectoris, myocarditis or cerebral infarction within 3 months
4) Patients whose circulatory dynamics are remarkably unstable due to severe heart failure, arrhythmia and the like (in the case where it is judged that it is desirable for cardiovascular medical specialists to avoid this treatment)
5) Patients with active infection
6) Patients whose are pregnant or might be pregnant
7) Patients with proliferative diabetic retinopathy (untreated, medium-term and late proliferative retinopathy)
the end of treatment example is excluded
8) Patients with less than serum albumin 2 mg/dL
9) Patients whose are judged inappropriate for this trial by their attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fukushima |
Organization
Kumamoto University
Division name
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences
Zip code
860-8556
Address
1-1-1 Honjo Chuo-ku Kumamoto, Japan
TEL
096-373-5233
s_fukushima@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikko |
| Middle name | |
| Last name | Kajihara |
Organization
Kumamoto University
Division name
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences
Zip code
860-8556
Address
1-1-1 Honjo Chuo-ku Kumamoto, Japan
TEL
096-373-5233
Homepage URL
kajiderma@gmail.com
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital: Ethics Committee for clinical research & advanced medical technology at the Faculty of Life Sciences, Kumamoto University
Address
1-1-1 Honjo,Kumamoto-shi,Kumamoto
Tel
(+81)096-373-5966
byi-senshin@jimu.kumamoto-u.ac.jp
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
| 2016 | Year | 11 | Month | 23 | Day |
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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 24 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 24 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 02 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027802
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/04/16 | 作業中_20210329_研究計画書_第4.0版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
