UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030700
Receipt number R000034215
Scientific Title Synovial stem cell transplantation for participants who deviate from clinical trial
Date of disclosure of the study information 2018/01/16
Last modified on 2019/01/25 11:38:30

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Basic information

Public title

Synovial stem cell transplantation for participants who deviate from clinical trial

Acronym

Synovial stem cell transplantation for participants who deviate from clinical trial

Scientific Title

Synovial stem cell transplantation for participants who deviate from clinical trial

Scientific Title:Acronym

Synovial stem cell transplantation for participants who deviate from clinical trial

Region

Japan


Condition

Condition

meniscus lesions

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety of autologous synovial stem cell transplantation after meniscus repair

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse event including type, frequency, severity and duration

Key secondary outcomes

1) Safety
Device-related adverse event data,including type, frequency,severity and duration
2) Efficacy
Lysholm score,Knee Injury and Osteoarthritis Outcome Score (KOOS),Numerical Rating Scale (NRS)


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 after meniscus repair

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 participated in clinical trial of autologous synovial stem cell transplantation after meniscus repair
2) Patients who were eligible for both shipping inspection and confirmation inspection below
- Sterility test
- Mycoplasma negative test
- Endotoxin test
- Packaging/Display

3) Patients for whom transplantation of autologous synovial stem cell products could not be carried out due to nonconformity for following inspections
- CFU evaluation
- Cell number, viable cell ratio
- Cell purity evaluation

Key exclusion criteria

1) Patients with active infection
2) Patient with poor controlled diabetes
3) Patients with complications as shown below and poor general condition.
- Severe cardiovascular disease
- Severe liver disease
- Severe renal dysfunction
- Poor mental illness with poor control
4) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study
5) Patient for whom doctors decide as not appropriate to participate in the clinical study

Target sample size

2


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Sekiya

Organization

Tokyo Medical and Dental University

Division name

Center for Stem Cell and Regenerative Medicine

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan

TEL

03-5803-4017

Email

sekiya.arm@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Office administrator

Organization

Medical Hospital of Tokyo Medical and Dental University

Division name

Clinical Research Center

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

TEL

03-5803-5612

Homepage URL

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

Email

tiken.crc@tmd.ac.jp


Sponsor or person

Institute

Medical Hospital of Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

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 01 Month 16 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

Completed

Date of protocol fixation

2017 Year 12 Month 18 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 16 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 01 Month 05 Day

Last modified on

2019 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034215


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name