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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035114
Receipt No. R000040022
Official scientific title of the study Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Date of disclosure of the study information 2018/12/03
Last modified on 2018/12/03

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Basic information
Official scientific title of the study Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Title of the study (Brief title) Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Region
Japan

Condition
Condition the enthesitis, enthesopathy and ligament injuries
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the enthesitis, enthesopathy and ligament injuries.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain, tenderness, Visual Analog Scale and Scale of returning to play after 1, 4, 8, 12 weeks from the injection
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The patient who has the enthesis, enthesitis and ligament injuries.
The patient who consents
The patient who does not have infections
Key exclusion criteria The patient who has infections
The patient who has fever over 37.0 degrees
The patient who has a wound
The patient who has oral treatment
Target sample size 20

Research contact person
Name of lead principal investigator Hiroki Funasaki
Organization Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Division name Department of Sports and Wellness Clinic
Address 3-25-8 Nishishinbashi Minato-ku Tokyo-to
TEL 03-3433-1111
Email ms05yusukemurayama@gmail.com

Public contact
Name of contact person Yusuke Murayama
Organization Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Division name Department of Sports and Wellness Clinic
Address 3-25-8 Nishishinbashi Minato-ku Tokyo-to
TEL 03-3433-1111
Homepage URL
Email ms05yusukemurayama@gmail.com

Sponsor
Institute Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Department of Sports and Wellness Clinic, The Jikei University 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)

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
2018 Year 12 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 28 Day
Anticipated trial start date
2018 Year 12 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information It is before starting examination today, third December 2018.

Management information
Registered date
2018 Year 12 Month 03 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040022

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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