UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017944 |
|---|---|
| Receipt number | R000020797 |
| Scientific Title | Phase I exploratory clinical research on the use of High-Density Mesenchymal Stem Cell Scaffold-Free Autologous Constructs derived from adipose tissue for the donor site of mosaic plasty plugs for osteochondral regeneration therapy |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2019/07/07 12:12:54 |
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Basic information
Public title
Phase I exploratory clinical research on the use of High-Density Mesenchymal Stem Cell Scaffold-Free Autologous Constructs derived from adipose tissue for the donor site of mosaic plasty plugs for osteochondral regeneration therapy
Acronym
Clinical research on osteochondral tissue regeneration using adipose derived mesenchymal stem cell constructs
Scientific Title
Phase I exploratory clinical research on the use of High-Density Mesenchymal Stem Cell Scaffold-Free Autologous Constructs derived from adipose tissue for the donor site of mosaic plasty plugs for osteochondral regeneration therapy
Scientific Title:Acronym
Clinical research on osteochondral tissue regeneration using adipose derived mesenchymal stem cell constructs
Region
| Japan |
Condition
Condition
Patients with cartilage injury, osteochondritis dissecans, disengaged osteochondral bone fracture, or idiopathic osteonecrosis of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and osteochondral regeneration using implanted "High-density Mesenchymal Scaffold-Free Stem Cell Autologous Construct (HDMAC)" derived from adipose tissue for donor site of mosaic plasty plugs
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence rate of the adverse events and side effects that occur after grafting
Key secondary outcomes
Evaluation of osteochondral regeneration in the HDMAC plug implanted area compared with the non implanted area by MRI and arthroscopy with ICRS scoring
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
| Medicine |
Interventions/Control_1
HDMAC plug implanted
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects must meet all of the eligibility listed below to be enrolled in the trial.
1) Age : >= 20 and <= 60 years old at the time of obtaining informed consent
2) Patients with cartilage injury, osteochondritis dissecans, disengaged osteochondral bone fracture or idiopathic osteonecrosis of the knee joint diagnosed by MRI
3) Patients have a lesion area (shoulder, knee, elbow, joint) larger than 100mm2
4) Patients with normal hematopoietic function (screening test results showing blood composition to be within the following ranges; white blood cell count (3,000-10,000/uL), platelet count (140,000-440,000/uL), hemoglobin (10.0-18.0g/dL).
5) Patients without serious problems on kidney (CRE;0.65-1.07mg/dL for male, 0.46-0.79 mg/dL for female) and liver (ALT;6-90U/L, AST;13-90U/L, total bilirubin;0.3-3.6mg/dL), uncontrolled heart dysfunctions including arrhythmia and angina pectoris, uncontrolled diabetes or high blood pressure
6) Suitable as a subject as results of screening test conducted after obtaining informed consent
7) Participate this trial based on subject's own free will and give informed consent in written form
Key exclusion criteria
Subjects that meet the following criteria will be excluded from the trial.
1) Has past undergone osteochondral surgery
2) Has past suppurative arthritis in the affected area
3) Has past rheumatism, gout or other arthritis
4) Has present or past contagious disease within 3 months of registering for the trial
5) Positive for syphilis , HBs antigens, HCV, HIV parvovirus or HTLV antigens in the screening test results
6) Was drawn 200ml of whole blood within one month (or 200ml of blood components was drawn within two weeks) of registering
7) Is currently taking antithrombotic or anticoagulant drugs
8) APTT over 41 seconds and PT over 13.5 seconds in the screening test results
9) Is currently undergoing treatment for a malignant tumor or underwent treatment for a malignant tumor (excluding intraepithelial neoplasia) within the last 5 years
10) Has any congenital metabolism or bone disorders
11) Has past history of drug or alcohol abuse
12) Is taking steroids like prednisolone systemically 5mg/day or is taking any immune suppressant drugs
13) Participate other clinical research within 3 months before registration
14) Has a history of drug hypersensitivity reactions (antibacterial agents using cultivated cells such as penicillin etc)
15) Has hypersensitivity for animals (especially for bovine)
16) Has a history of anaphylaxis
17) Pregnant, capable of pregnancy and lactating women
18) Unsuitable for this trial judged by PI or SI
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Nakashima |
Organization
Kyushu University Hospital
Division name
Department of Orthopedic Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka
TEL
092-642-5488
yasunaka@ortho.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Akasaki |
Organization
Kyushu University Hospital
Division name
Department of Orthopedic Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka
TEL
092-642-5488
Homepage URL
akasaki@ortho.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital Department of Orthopedic Surgery
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical and Translational Research
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka
Tel
092-642-5082
byshasiwatas@jimu.kyushu-u.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
九州大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
5
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020797
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| Registered date | File name |
| Research case data | |
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