UMIN-CTR Clinical Trial

Basic information
Public title	Safety of platelet rich plasma injection for muscle strain
Acronym	Safety of platelet rich plasma injection for muscle strain
Scientific Title	Safety of platelet rich plasma injection for muscle strain
Scientific Title:Acronym	Safety of platelet rich plasma injection for muscle strain
Region	Japan

Condition
Condition	muscle strain
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To ascertain the safety of platelet-rich plasma injection for patients who received muscle strain diagnosed as Okuwaki classification grade 2.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Adverse events occurring during platelet-rich plasma use and observation period and its details
Key secondary outcomes	Clinical outcome after using platelet-rich plasma, time course change with MRI

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	Device,equipment
Interventions/Control_1	For patients diagnosed as Okuwaki classification type II by MRI, Platelet-rich plasma is infiltrated to the muscle injured area under ultrasound guided within 7 days after injury
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1.acute muscle strain 2.Patients diagnosed with Okuwaki classification type II by taking for MRI 3.Be able to treat under ultrasound guidance at our hospital within 1 week after injury 4.Be observable throughout the entire research period
Key exclusion criteria	a history of infectious disease and systemic disorders such as diabetes, rheumatoid arthritis, hematological diseases (coagulopathy), severe cardiovascular diseases, infections, or immunodepression; therapy with anticoagulants or an anti-aggregating agent; use of non-steroidal anti-inflammatory drugs 2 weeks before blood sampling; and hemoglobin levels <10 g/dL.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masashi Yamazaki
Organization	University of Tsukuba
Division name	Department of Orthopaedics Surgery, Faculty of Medicine
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
TEL	+81298533219
Email	masashiy@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomokazu Yoshioka
Organization	University of tsukuba
Division name	Division of Regenerative Medicine for Musculoskeletal System
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
TEL	+81298533219
Homepage URL
Email	tymd99@tsukuba-seikei.jp

Sponsor
Institute	Department of Orthopaedics Surgery, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	Grant of Japan Sports Medicine Foundation 2016
Organization
Division
Category of Funding Organization	Non profit foundation
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	2017 Year 11 Month 01 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	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date	2017 Year 12 Month 01 Day
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	2017 Year 09 Month 25 Day
Last modified on	2018 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033463

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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