Unique ID issued by UMIN | UMIN000034227 |
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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 |
Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Japan |
lumbar disc herniation
Orthopedics |
Others
NO
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.
Safety,Efficacy
Exploratory
Explanatory
Phase I,II
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.
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Device,equipment |
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.
20 | years-old | <= |
50 | years-old | > |
Male and Female
(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
(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
40
1st name | Hideki |
Middle name | |
Last name | Sudo |
Hokkaido University Hospital
department of orthopedic surgery
060-8638
North-15, West-7, Kita-ku, Sapporo, Hokkaido
011-716-5936
hidekisudo@yahoo.co.jp
1st name | Nozomi |
Middle name | |
Last name | Yokota |
Hokkaido University Hospital
Clinical Research and Medical Innovation Center
060-8638
North-14, West-5, Kita-ku, Sapporo, Hokkaido
011-706-7735
nozomi.yokota@huhp.hokudai.ac.jp
Hokkaido University Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
MOCHIDA PHARMACEUTICAL CO., LTD.
Hokkaido University Hospital Institutional Review Board
North-14, West-5, Kita-ku, Sapporo, Hokkaido
011-706-7061
tiken@med.hokudai.ac.jp
NO
北海道大学病院(北海道)、えにわ病院(北海道)
2018 | Year | 09 | Month | 21 | Day |
https://www.sciencedirect.com/science/article/pii/S245186542100106X?via%3Dihub
Unpublished
41
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.
2023 | Year | 09 | Month | 12 | Day |
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.
Patients with dMD-001 implanted were followed up for 6 months after implantation.
No adverse events occurred after dMD-001 implantation.
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 .
none
none
Completed
2018 | Year | 07 | Month | 05 | Day |
2018 | Year | 08 | Month | 28 | Day |
2018 | Year | 09 | Month | 21 | Day |
2021 | Year | 11 | Month | 01 | Day |
2018 | Year | 09 | Month | 21 | Day |
2023 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039018
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