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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032134
Receipt No. R000036663
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
Date of disclosure of the study information 2018/04/06
Last modified on 2018/04/06

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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
Middle name
Last name Hiroki Funasaki
Organization Jikei University
Division name Orthopedic
Zip code
Address 3-19-18,Nishi shinnbashi, Minato-ku
TEL 0334331111
Email seikeigeka@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rei Tsuruga
Organization Jikei University
Division name Orthopedic
Zip code
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
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 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
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
2018 Year 04 Month 06 Day


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

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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