UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034227
Receipt number R000039018
Scientific Title Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Date of disclosure of the study information 2018/09/21
Last modified on 2023/09/12 16:34:36

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Basic information

Public title

Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation

Acronym

Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation

Scientific Title

Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation

Scientific Title:Acronym

Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation

Region

Japan


Condition

Condition

lumbar disc herniation

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this trial is to evaluate the feasibility and safety of dMD-001 implantation in patients after lumbar disc herniation, as a primary endpoint. We will explore the performance secondarily.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

1) Feasibility dMD-001 implantation
The feasibility is evaluated as the implant achievement rate. With regard to implantation of dMD-001, judgment is made based on the criteria before or in surgery, and it is judged that implantation of dMD-001 is completed with the surface of dMD-001 being completely gelled.
2) Safety
Adverse events occurred 24 weeks after implantation of dMD-001 are summarized as safety assessments. Safety is assessed with the incidence of adverse events that can not deny the relationship with dMD-001.

Key secondary outcomes

1) VAS
2) FFD
3) SLR test
4) Modified Schober's test
5) JOA score
6) SF-36
7) ODI
8) RDQ
9) JOABPEQ
10) MRI signal change
11) Evaluation of dMD-001 implantation


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Participants will undergo the standard discectomy followed by Sodium Alginate solution injection. The Sodium Alginate solution (up to 2ml) will be placed into the intervertebral disc cavity using a syringe and 10ml of 0.1 mol/l CaCl2 solution will be applied to the surface of the Sodium Alginate solution to gelate the alginate. Five minutes after the application of CaCl2 solution, the surgical site will be irrigated with a full-dose of sterile clinical grade normal saline.

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Patients with lumbar disc herniation to plan discectomy
(2) MRI evidence of intervertebral disc herniation corresponding to symptoms
(3) Unresponsive to 6 consecutive weeks of therapy or experiencing acute/uncontrolled leg pain (80 mm or more out of 100 mm with VAS)
(4) Candidate for a one-level lumbar discectomy procedure
(5) Persistent and predominant leg pain (40 mm or more out of 100 mm with VAS)
(6) Aged 20-50
(7) Informed consent is obtained after the sufficient explanation of this study

Key exclusion criteria

(1) Previous surgery involving index lumbar level
(2) Prior or planned procedure to fuse the lumbar spine
(3) The posterior bending angle of the intervertebral disc is recognized in any of the anterior bending, middle, and posterior bending of the lumbar spine X-ray image
(4) Greater than grade I spondylolisthesis or retrolisthesis at affected level
(5) Cauda equina syndrome
(6) Acute local or systemic infection
(7) Active malignancy or other similar comorbidities
(8) Drug-dependent patients or alcohol dependence patients
(9) Patients suffering from mental illness
(10) Current fracture, tumour and/or deformity of the lumbar spine
(11) Currently breast-feeding, pregnant, pregnancy during the trial period, or cannot do a highly effective contraceptive method
(12) Other clinical trials within 4 weeks
(13) Presence of any implanted metal or other contraindication to MRI
(14) Diagnosed as positive for allergic reactions to sodium alginate by allergy test (prick test)
(15) Contraindicated for this study due to other reasons

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Sudo

Organization

Hokkaido University Hospital

Division name

department of orthopedic surgery

Zip code

060-8638

Address

North-15, West-7, Kita-ku, Sapporo, Hokkaido

TEL

011-716-5936

Email

hidekisudo@yahoo.co.jp


Public contact

Name of contact person

1st name Nozomi
Middle name
Last name Yokota

Organization

Hokkaido University Hospital

Division name

Clinical Research and Medical Innovation Center

Zip code

060-8638

Address

North-14, West-5, Kita-ku, Sapporo, Hokkaido

TEL

011-706-7735

Homepage URL


Email

nozomi.yokota@huhp.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University 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)

MOCHIDA PHARMACEUTICAL CO., LTD.


IRB Contact (For public release)

Organization

Hokkaido University Hospital Institutional Review Board

Address

North-14, West-5, Kita-ku, Sapporo, Hokkaido

Tel

011-706-7061

Email

tiken@med.hokudai.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

北海道大学病院(北海道)、えにわ病院(北海道)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 21 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S245186542100106X?via%3Dihub

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

41

Results

dMD-001 was implanted for all patients.
No adverse events occurred after dMD-001 implantation.
The outcome of pain assessment showed that the VAS scores for low back and lower extremity pains improved significantly as compared with the preoperative scores.
MRI analysis showed that the Pfirrmann disc degeneration grade improved significantly postoperatively compared to preoperatively.

Results date posted

2023 Year 09 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Forty patients (30 men and 10 women; mean age: 36.3 y) were enrolled in the study and completed the 6-month postoperative follow-up. The IVD herniation levels were L4/in 30 patients.

Participant flow

Patients with dMD-001 implanted were followed up for 6 months after implantation.

Adverse events

No adverse events occurred after dMD-001 implantation.

Outcome measures

dMD-001 was implanted for all patients.
The outcom of pain assessment showed that the VAS scores for low back and lower extremity pains improved significantly as compared with the preoperative scores.
MRI analysis showed that the Pfirrmann disc degeneration grade improved significantly postoperatively compared to preoperatively .

Plan to share IPD

none

IPD sharing Plan description

none


Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 07 Month 05 Day

Date of IRB

2018 Year 08 Month 28 Day

Anticipated trial start date

2018 Year 09 Month 21 Day

Last follow-up date

2021 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 21 Day

Last modified on

2023 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039018


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name