UMIN-CTR Clinical Trial

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
Email	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
Email	akasaki@ortho.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital Department of Orthopedic Surgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020797