UMIN-CTR Clinical Trial

Basic information
Public title	Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Acronym	Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Scientific Title	Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Scientific Title:Acronym	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	1st name Middle name Last name Hiroki Funasaki
Organization	Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Division name	Department of Sports and Wellness Clinic
Zip code
Address	3-25-8 Nishishinbashi Minato-ku Tokyo-to
TEL	03-3433-1111
Email	ms05yusukemurayama@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Yusuke Murayama
Organization	Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Division name	Department of Sports and Wellness Clinic
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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	Preinitiation
Date of protocol fixation	2018 Year 11 Month 28 Day
Date of IRB
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

Other
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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