UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
A Prospective Multi-centre, Randomised, Controlled Study to Evaluate the Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis by Interbody Fusion (L1 - S1).

一般向け試験名略称/Acronym

日本語

英語
Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis. ( Spine1 )

科学的試験名/Scientific Title

日本語

英語
A Prospective Multi-centre, Randomised, Controlled Study to Evaluate the Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis by Interbody Fusion (L1 - S1).

科学的試験名略称/Scientific Title:Acronym

日本語

英語
Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis. ( Spine1 )

試験実施地域/Region

欧州/Europe

対象疾患名/Condition

日本語

英語
Spondylolisthesis

疾患区分1/Classification by specialty

整形外科学/Orthopedics

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語

英語
To evaluate the safety (local and systemic) of a specific surgical intervention with the use of NVD 001 (AEs, AESI, SAEs) in patients with symptomatic low-grade degenerative spondylolisthesis grade I or II undergoing surgery for spinal fusion of one vertebral segment (L1-S1).

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

説明的/Explanatory

試験のフェーズ/Developmental phase

第Ⅰ・Ⅱ相/Phase I,II

主要アウトカム評価項目/Primary outcomes

日本語

英語
During the first year post surgery, safety will be assessed by:
- Collecting all adverse events for incidence, severity, relatedness, required action and outcome.
- Collecting all SAEs (also SAEs during second year follow-up)
- Collecting Adverse Events of Special Interest (AESI) (also at 24 months post-surgery) as part of local and systemic toxicity such as:
Signs of local toxicity of experimental product will be evaluated on CT and radiographic images by local and independent radiologist and include:
-- Trabecular bone resorption
-- Intravertebral cystic changes
-- Soft tissue calcification/ossification
-- Peridiscal soft tissue swelling
-- Hyperostosis
-- Tumour growth
Signs of systemic toxicity will be evaluated on chest radiographs by local radiologist and include appearance of calcification/ ossification on serial X-rays in comparison with preoperative X-rays.
-- Ectopic bone formation
- Surgical intervention-related safety parameters
- Safety laboratory parameters
- Safety evaluations including Electrocardiography, vital signs, physical and neurological examinations

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
- Evaluation of fusion will be assessed on CT-Scans(*) at 6, 9, 12 and 24 months post-surgery by qualitative visual analysis called the "bridging trabecular bone scale" (Sys et al, 2011).
(*) Coronal and sagittal computed tomography scan: spiral CT with thin acquisition of axial images, in Digital Imaging and Communications in Medicine (DICOM) format.
- Evaluation of Non-fusion will be assessed on Dynamic Radiographs at 6, 9, 12 and 24 months post-surgery and considered as non-fusion if at least one of the following signs occurs: translational motion more than 3 mm; angular motion more than 5deg; vacuum phenomenon in operated disc.
- Evaluation of bone production will be done on CT images and will be quantified by using specific software at 6, 9, 12 and 24 months post-surgery. Two quantitative parameters will be addressed on serial CT with discharge CT data as baseline (of the patient's spine condition):
-- Surface of new bone production (Huang et al, 2014)
-- Determination of Hounsfield Unit (HU) in selected areas (in the PEEK cage(s) and in the entire disc).
- Functional assessment by means of Oswestry Disability Index (ODI) at screening, 1, 6, 9, 12 and 24 months post-surgery.
- Pain assessment by means of Brief Pain Inventory (BPI) at screening, pre-operation, discharge, 1, 6, 9, 12 and 24 months post-surgery.
- Overall Treatment Effect scale (OTE) at 1, 6, 9, 12 and 24 months post-surgery.
- Quality of life assessment by means of questionnaire EuroQoL 5 Dimensions (EQ-5D-5L) at screening, 9, 12 and 24 months post-surgery.
- Surgical parameters such as duration of surgery, duration of postoperative hospital stay, subsequent surgical interventions (revision, removal, reoperation and supplemental fixation).

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

オープンだが測定者がブラインド化されている/Open -but assessor(s) are blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

はい/YES

動的割付/Dynamic allocation

はい/YES

試験実施施設の考慮/Institution consideration

動的割付けの際に施設を調整因子としている/Institution is considered as adjustment factor in dynamic allocation.

ブロック化/Blocking

はい/YES

割付コードを知る方法/Concealment

中央登録/Central registration

群数/No. of arms

2

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

医薬品/Medicine

介入1/Interventions/Control_1

日本語

英語
Experimental: NVD-001
Autologous osteogenic cells in ECM with DBM
At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with NVD-001.

介入2/Interventions/Control_2

日本語

英語
Active Comparator: Standard of Care
Best standard of care in surgical practice
At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with autologous locally harvested cancellous bone (laminectomy)

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

18

歳/years-old

より上/<

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
-Subject has understood and accepted to participate in the study according to all study procedures by signing the approved informed consent.
-Male or female subjects aged >18 and is skeletally mature (epiphyses closed).
-Subject has clinically important pain or neurological symptoms with or without claudication due to symptomatic degenerative spondylolisthesis grade I or II (Meyerding Classification).
-Conservative treatment of disease has failed for at least 3 months since diagnosis. (ISASS 2011)
-Subject has a preoperative ODI score > 30.
-Subject has an indication for spinal fusion of one vertebral segment (L1-S1) due to symptomatic degenerative spondylolisthesis grade I or II diagnosed by computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and/or dynamic radiography.
-Subject is suitable for surgical operation and incorporation of the PEEK cage(s) by transforaminal lumbar interbody fusion (TLIF) or posterior lumbar intervertebral fusion (PLIF) by minimally invasive or open approach in one mobile segment (L1- S1) with bilateral rigid fixation. No posterolateral lumbar fusion (PLF) technique is allowed.
-Subject is, in the Investigator?s opinion, psychosocially, mentally and physically able to fully comply with this protocol, including the postoperative regimen and follow-up visits.
-Safety laboratory test results and pre-surgery serology are clinically acceptable to undergo surgery as applicable Serology panel for HIV, HBV, HCV, HTLV I/II and syphilis must be negative.
-Women of childbearing potential (WOCBP) including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test. Results have to be available and negative for the patient to be entered in the study.
-WOCBP have to use an effective method of birth control 2 months prior to study entry or to surgical intervention date and throughout the study duration.

除外基準/Key exclusion criteria

日本語

英語
-Subject has known history of hypersensitivity or anaphylactic reaction to PEEK.
-Due to medical or other reasons spine fusion cannot be delayed for up to 6 months.
-Indications for spinal fusion other than symptomatic degenerative spondylolisthesis grade I and II (Meyerding Classification).
-Subject has documented metabolic disease such as but not limited to severe osteoporosis, osteogenesis imperfect, or osteomalacia.
-Subject with poorly controlled diabetes mellitus as assessed by glycohaemoglobin (HbA1c) > 8% (at least 2 values per year for last 2 years)
-Subject is underweight, i.e. body mass index (BMI) <= to 18.5 or has a BMI of >= to 40, or >= to 35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes.
-Overt or active local or systemic infection.
-Subject has a history of previously attempted spinal fusion at the same level, or spine level immediately adjacent to the level to be operated. Decompressive surgery alone (laminectomy) is not an exclusion criterion.
-Pregnant or breast-feeding woman.
-Subject had an acute fracture of the spine within 6 months prior enrolment in the study.
-Subject is currently taking chronically any medications that might affect bone metabolism or the quality of bone formation such as but not limited to bisphosphonates, steroids, methotrexate, anticoagulant therapies, immunosuppressants or immunotherapy.
-Subject is positive for human immunodeficiency virus (HIV) 1 or 2, hepatitis B or C, human T-cell lymphotropic virus (HTLV) 1 or 2, or syphilis at screening.
-Any clinically relevant chronic disease associated with renal or hepatic insufficiency or any chronic disease of such severity that surgery could be detrimental to the survival of the patient.
-Subject is on chronic immunosuppressive therapy due to inflammatory or systemic disease.
-Subject has a history of any autoimmune disease.

-(other crietria apply)

目標参加者数/Target sample size

36

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Christian
ミドルネーム
姓	Raftopoulos, MD, PhD

所属組織/Organization

日本語

英語
Saint-Luc University Hospital

所属部署/Division name

日本語

英語
Department of Neurosurgery

郵便番号/Zip code

1200

住所/Address

日本語

英語
Hippocrate Avenue 10 - 1200 Brussels - Belgium

電話/TEL

3227641088

Email/Email

christian.raftopoulos@uclouvain.be

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	Denis
ミドルネーム
姓	Dufrane, MD, PhD

組織名/Organization

日本語

英語
Novadip Biosciences

部署名/Division name

日本語

英語
Medical Officer

郵便番号/Zip code

1435

住所/Address

日本語

英語
Watson and Crick Hill, Rue Granbonpre 11, B-1435 Mont-Saint-Guibert - Belgium

電話/TEL

3210779220

試験のホームページURL/Homepage URL

https://www.novadip.com/

Email/Email

clinical@novadip.com

機関名/Institute

日本語
その他

英語
Novadip Biosciences
Watson and Crick Hill
Rue Granbonpre 11
B-1435 Mont-Saint-Guibert - Belgium

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Novadip Biosciences
Watson and Crick Hill
Rue Granbonpre 11
B-1435 Mont-Saint-Guibert - Belgium

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

海外/Outside Japan

研究費拠出国/Nationality of Funding Organization

日本語

英語
Belgium

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語

英語
Comite d Ethique Hospitalo-Facultaire Universite Catholique de Louvain Faculte de medecine

住所/Address

日本語

英語
Avenue Hippocrate 55-14, Tour Harvey niv 0, 1200 Brussel- Belgium

電話/Tel

3227645514

Email/Email

commission.ethique-saint-luc@uclouvain.be

他機関から発行された試験ID/Secondary IDs

はい/YES

試験ID1/Study ID_1

EudraCT 2016-002642-23

ID発行機関1/Org. issuing International ID_1

日本語

英語
EMA

試験ID2/Study ID_2

NCT03100032

ID発行機関2/Org. issuing International ID_2

日本語

英語
U.S. National Institutes of Health

治験届/IND to MHLW

試験実施施設名称/Institutions

(none in Japan)

一般公開日（本登録希望日）/Date of disclosure of the study information

2017

年

02

月

08

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

36

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2016

年

08

月

08

日

倫理委員会による承認日/Date of IRB

2016

年

11

月

28

日

登録・組入れ開始（予定）日/Anticipated trial start date

2017

年

01

月

01

日

フォロー終了(予定)日/Last follow-up date

2020

年

12

月

31

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2017

年

02

月

08

日

最終更新日/Last modified on

2021

年

05

月

27

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000029156

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029156