UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032134 |
|---|---|
| Receipt number | 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 | 2020/04/08 12:13:31 |
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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 | 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
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
tsuruga1021@gmail.com
Sponsor or person
Institute
Jikei University
Orthopedic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036663
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
