UMIN-CTR Clinical Trial

Basic information
Public title	Safety and effectiveness of autologous leukocyte-rich platelet-rich plasma therapy (L-PRP therapy) for damage, deficit and prolonged healing in the musculoskeletal system of the human body
Acronym	Safety and effectiveness of autologous leukocyte-rich platelet-rich plasma therapy (L-PRP therapy)
Scientific Title	Safety and effectiveness of autologous leukocyte-rich platelet-rich plasma therapy (L-PRP therapy) for damage, deficit and prolonged healing in the musculoskeletal system of the human body
Scientific Title:Acronym	Safety and effectiveness of autologous leukocyte-rich platelet-rich plasma therapy (L-PRP therapy)
Region	Japan

Condition
Condition	intractable muscle of damaged tendon attachment and muscle tendon transitiontendonitis, humeral superior condylitis, elbow medial collateral ligament injury, knee medial collateral ligament injury
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For patients with intractable muscle weakness, patellar tendonitis, humeral epicondylar lateral epicondylitis, elbow medial collateral ligament injury, knee medial collateral ligament injury that damaged tendon attachment and muscle tendon transition, L - PRP We will conduct therapy and examine its safety and effectiveness.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Self and other senses Clinical laboratory test (blood test Physical findings Visual Analog Scale Sports Reversion Scale
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	Other
Interventions/Control_1	Self-High Leukocyte Platelet Rich Plasma Therapy
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	Patients with target disease Patients who got consent in writing from the person or the substitute Patients without bacterial infection Age is over 20 years old, gender does not matter
Key exclusion criteria	Patients with bacterial infections in the whole body or in areas undergoing this treatment Patients who are suggestive of the possibility of affecting the general condition when infection is caused by this therapy Patients who have a fever of 37 degrees or more without using antipyretics or anti-inflammatory analgesics Patients with open wounds Patients during oral treatment
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Funasaki
Organization	Jikei University
Division name	Orthopedic
Zip code	1050003
Address	3-19-18,Nishi shinnbashi, Minato-ku
TEL	0334331111
Email	seikeigeka@jikei.ac.jp

Public contact
Name of contact person	1st name Rei Middle name Last name Tsuruga
Organization	Jikei University
Division name	Orthopedic
Zip code	1050003
Address	3-19-18,Nishi shinnbashi, Minato-ku
TEL	08054861238
Homepage URL
Email	tsuruga1021@gmail.com

Sponsor
Institute	Jikei University Orthopedic
Institute
Department

Funding Source
Organization	Jake University Orthopedic
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	Jikei University
Address	3-19-18,Nishi shinnbashi, Minato-ku
Tel	0334331111
Email	saiseiiryo@jikei.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	2018 Year 04 Month 06 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 04 Month 09 Day
Date of IRB
Anticipated trial start date	2018 Year 04 Month 09 Day
Last follow-up date	2021 Year 04 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 06 Day
Last modified on	2020 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036663