UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026383
Receipt number R000030110
Scientific Title Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions
Date of disclosure of the study information 2017/05/01
Last modified on 2020/03/05 10:25:10

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Basic information

Public title

Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions

Acronym

Autologous synovial MSCs for meniscus lesions

Scientific Title

Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions

Scientific Title:Acronym

Autologous synovial MSCs for meniscus lesions

Region

Japan


Condition

Condition

meniscus lesions

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of autologous synovial stem cells transplanted on the meniscal lesions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Lysholm score

Key secondary outcomes

1) Efficacy
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Numerical Rating Scale (NRS)
Knee X-ray examination,
MRI 3D analysis (meniscal thickness, height, width)
MRI analysis of meniscal / cartilage degeneration

2) Safety
Adverse event and device-related adverse event data, including type, frequency, severity and duration


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

Maneuver Other

Interventions/Control_1

Transplantation of autologous synovial stem cells on the meniscal lesions.

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

1) Patients who are aged 20 years or older on the acquisition date of informed consent before clinical study, and who can give a written informed consent
2) Patients with meniscus injuries including radial, vertical flap, horizontal flap, horizontal, degenerative or complex tear and patients with meniscus injuries located in the avascular area
3) Patients with clinical symptoms of meniscus injury, including pain
4) Patients with one or more of the following symptoms in the knee:
-catching sensation
-instability feeling
-limited range of motion
-hydrarthrosis
5) Patients who are indicated for menisectomy of 100 mm2 or larger because of (2) to (4)

Key exclusion criteria

1) Patient who is unidentified
2) Patients who underwent menisectomy or meniscus repair in the affected knee
3) Patients whose clinical symptoms have been sufficiently improved by conservative treatments in the last 3 months
4) Patients with knee malalignment.
5) Patients with a history of trauma in the knee
6) Patients for whom MRI is not indicated because of claustrophobia and so on
7) Patients who have had any intraarticular injections (local anesthetic agent, corticosteroid agent, hyaluronic acid) or arthrocentesis in these 3 months.
8) Patients with active infection
9) Patients diagnosed or suspected as malignant tumor in these 5 years
10) Patients sensitive to antibiotics (penicillin, streptomycin or amphotericin B)
11) Patients sensitive to animal (bovine) origin materials
12) Patients with poor controlled diabetes
13) Patients with a pacemaker
14) Patients with poor general condition with following complication;
-severe cardiovascular disease
-severe liver disorder
-severe kidney dysfunction
-poorly controlled psychiatric disorder
-other diseases which sudden deterioration or aggravation is foreseeable during the study period
15) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study
16) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product
17) Patient for whom doctors decide as not appropriate to participate in the clinical study

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Ichiro
Middle name
Last name Sekiya

Organization

Tokyo Medical and Dental University

Division name

Center for Stem Cell and Regenerative Medicine

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-4017

Email

sekiya.arm@tmd.ac.jp


Public contact

Name of contact person

1st name Office
Middle name
Last name Administrator

Organization

Tokyo Medical and Dental University, Medical Hospital

Division name

Clinical Research Center

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5612

Homepage URL

http://www.tmd.ac.jp/medhospital/topics/

Email

tiken.crc@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University, Medical Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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

Tokyo Medical and Dental University Hospital of Medicine, Institutional Review Board

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

Tel

03-5803-5612

Email

tiken.crc@tmd.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

東京医科歯科大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 05 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

10

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

in preparation for submission

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

Completed

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 02 Month 27 Day

Anticipated trial start date

2017 Year 07 Month 29 Day

Last follow-up date

2019 Year 02 Month 21 Day

Date of closure to data entry

2019 Year 04 Month 28 Day

Date trial data considered complete

2019 Year 05 Month 10 Day

Date analysis concluded

2019 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 03 Day

Last modified on

2020 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030110


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name