UMIN-CTR Clinical Trial

Public title

Healing acceleration of repaired meniscus by synovial stem cells

"Clinical study to assess the safety and efficacy of transplantation of autologous synovial mesenchymal stem cells in patients with knee meniscal tear"

Acronym

Healing acceleration of repaired meniscus by synovial stem cells

Scientific Title

Healing acceleration of repaired meniscus by synovial stem cells

"Clinical study to assess the safety and efficacy of transplantation of autologous synovial mesenchymal stem cells in patients with knee meniscal tear"

Scientific Title:Acronym

Healing acceleration of repaired meniscus by synovial stem cells

Region

Japan

Condition

Knee meniscal tear

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To improve the clinical results of meniscal repair, autologous synovial stem cells are transplanted to the sutured meniscus after meniscal repair in patients with meniscal tear to which meniscal resection is applied at present. The main purpose of this study is to evaluate the safety and efficacy of transplantation of autologous synovial stem cells.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Safety of clinical research is evaluated on the presence, severity and frequency of adverse events caused by autologous synovial stem cells.

Key secondary outcomes

1) Feasibility of the quality control of cultured synovial stem cells
2) Subjective symptom (KOOS and NRS scores based on patient-oriented evaluation) and knee symptom before and after 4, 6, 12, 24 weeks of meniscal repair.
3) MRI assessment of sutured meniscus before and after 12, 24 weeks of meniscal repair
4) Width of joint space evaluated by X-ray examination before and after 12, 24 weeks of meniscal repair

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

meniscal repair and transplantation of autologous synovial stem cells to the sutured meniscus

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Meniscal tear such as radial tear, horizonal flap tear, complex tear and degenerative tear to which meniscal resection is generally applied
2) Patients with clinical symptoms such as knee joint unstability, limitation in range of motion, hydrathrosis and pain
3) Patients approved for treatment with surgery
4) Patients to whom meniscal repair is technically possible
5) Patients older than 20 years on the acquisition date of informed consent before clinical study
6) Patients who gave a written informed consent

Key exclusion criteria

1) Patients who didn't give a written informed consent
2) Patients with active infection
3) Patients positive for HIV (HIV-1, HIV-2), HBV, HCV, or HTLV-1
4) Patients with active malignant tumors
5) Patients with sensitivity to antibiotic
6) Pregnant or breast-feeding women
7) Patients with diabetes
8) Patients in bad general condition
9) Patients evaluated as a contraindication to the clinical study by one's doctor

Target sample size

5

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, 113-8519, Japan

TEL

03-5803-4977

Email

sekiya.arm@tmd.ac.jp

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

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

National government

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科歯科大学医学部附属病院（東京都）

Date of disclosure of the study information

2013

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

08

Month

30

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

22

Day

Last follow-up date

2015

Year

04

Month

21

Day

Date of closure to data entry

Date trial data considered complete

2015

Year

05

Month

18

Day

Date analysis concluded

2015

Year

08

Month

28

Day

Other related information

Registered date

2013

Year

09

Month

27

Day

Last modified on

2015

Year

10

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013889