AzTrials
AzTrials

SpondylolisthesisPhase 1/2Spine1NCT03100032

Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis

A Phase 1/2 study testing NVD-001 in people with Spondylolisthesis, run by Novadip Biosciences at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spondylolisthesis
What is being tested?
NVD-001
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
12 sitesin 3 countries
Study dates
Jan 2017to Jun 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any subject meeting all of the following inclusion criteria and verified by the Investigator during the screening period:
  • 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.
Show all 19Show fewer
  • 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.
  • At screening, local laboratory safety test results are clinically acceptable and serology results for HIV, HBV, HCV, HTLV I/II and syphilis are in accordance with country specific requirements for donation of Human Body Material. At time of adipose tissue collection, central laboratory serology and molecular test panel for HIV, HBV, HCV, HTLV I/II and syphilis must be in accordance with Belgian specific requirements for release of Human Body Material.
  • 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 (defined as a method which results in a failure rate of less than 1% per year) such as:
  • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomised partner (provided that partner is the sole sexual partner of the trial participant and that the surgical success of vasectomy has been confirmed)
  • Sexual abstinence For each case of delayed menstrual period, confirmation of absence of pregnancy is strongly recommended. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycles. In case a urine pregnancy test is positive, a confirmatory blood pregnancy test is obligatory.

Who cannot join

  • Any subject meeting any of the following exclusion criteria verified by the Investigator during the screening period will be excluded from enrolment into the study.
  • 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 displays drug or alcohol dependence, serious current illness, mental illness or extenuating circumstance or any other factors which, in the opinion of the Investigator, will interfere with study conduct or interpretation of the results.
  • Subject has documented metabolic disease such as but not limited to severe osteoporosis, osteogenesis imperfect, or osteomalacia.
Show all 26Show fewer
  • 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) ≤18.5 or has a BMI of ≥40, or ≥35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes at V0a.
  • Overt or active local or systemic infection, including latent infection around (area of) the future surgical implant site.
  • Subject has a history of previously attempted spinal fusion at the same level, or spine level immediately adjacent to the level to be operated on in this study. Decompressive surgery alone (laminectomy) is not an exclusion criterion.
  • Subject is on a transplant list or having received a solid organ transplant at any point in the past.
  • Pregnant or breast-feeding woman.
  • Involved in or planning to engage in litigation related health problems.
  • Subject is a prisoner.
  • Subject had an acute fracture of the spine within 6 months prior V0a in the study.
  • Subject is known to require additional surgery to the lumbar spinal region within the next 2 years after 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 currently using an electrical bone growth stimulator
  • Subject is positive for human immunodeficiency virus (HIV) 1 or 2, hepatitis B (HBsAg or PCR positive) or C, human T-cell lymphotropic virus (HTLV) 1 or 2, or syphilis at screening (V0a).
  • Subject was exposed to any experimental therapy with another investigational drug within 60 days prior to screening or enrolment in any concurrent study that may confound the results of this study.
  • Subject previously received a cellular therapy (at any point in time).
  • Subject was exposed to therapy for a malignancy or pre-malignant entity, and not confirmed disease-free for 5 years or more.
  • 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.
  • Any other illness which might reduce life expectancy to less than 2 years from screening.
  • Subject is on chronic immunosuppressive therapy (immunosuppressants/immunotherapy) due to inflammatory or systemic disease.
  • Subject has an active inflammatory systemic autoimmune disease that could interfere with bone metabolism such as but not limited to rheumatoid arthritis, ankylosing spondylarthritis, inflammatory bowel disease, systemic lupus erythematosus or thyroid diseases.

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

Belgium6 sites

  • Hôpital Erasme - Neurosurgery Department

    Brussels, 1070

  • Universitair ziekenhuis Brussel - Brussels Health Campus - Department of Orthopaedics and Traumatology

    Brussels, 1090

  • Saint-Luc University Hospital

    Brussels, 1200

  • Algemeen Ziekenhuis Monica O.L.V. - Campus Deurne

    Deurne, 2100

  • Ziekenhuis Oost-Limburg, Campus Sint-Jan

    Genk, 3600

  • Centre Hosp. Univ. UCL - Namur site Godinne - Service de neurochirurgie

    Yvoir, 5530

Other trials in Belgium

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Szpital Św. Rafała

    Krakow, 30-693

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. W. Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego

    Poznan, 61-545

Other trials in Poland

Czechia2 sites

  • Fakultní nemocnice Brno

    Brno, 625 00

  • Fakultní nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

About this study

Official title: 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)

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).

Read the detailed description

This is 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 of one vertebral segment (L1-S1). The study consists of a 12-month initialfollow-up period post-surgery and a subsequent 12-month long term follow-up.

NVD-001 is an autologous cellular medicinal product obtained by culture of adipose tissue (liposuction) leading to osteogenic cells after ex vivo isolation, expansion and differentiation of pluripotent adipose-tissue stem cells (ASC), and combination with an allogeneic fully demineralised bone matrix into a 3D bone implant.

Patients diagnosed with symptomatic degenerative spondylolisthesis grade I or II with an indication for spinal fusion of one vertebral segment (L1-S1) who sign informed consent and are eligible will be randomised either to the experimental group (surgical intervention for spinal lumbar interbody fusion with NVD-001) or to the control group (commonly used surgical intervention for spinal lumbar interbody fusion (TLIF, PLIF, minimally invasive or open approach) with one or two PEEK cage(s) filled and surrounded by locally harvested autologous cancellous bone (laminectomy).

Being tested
NVD-001, Standard of Care
Keywords
Spinal Fusion, Lumbar Interbody Fusion, Autologous Stem Cell Therapy, Bone Graft, Demineralized Bone Matrix, Polyetheretherketone (PEEK) cage
Medical subject headings
Spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NVD-001Biological

    At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with NVD-001.

  • Standard of CareProcedure or surgery

    At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with autologous locally cancellous bone (laminectomy)

Study groups in NCT03100032
Study groupRoleWhat they receive
NVD-001ExperimentalAutologous osteogenic cells in ECM with DBM
Receives: Biological: NVD-001
Standard of CareActive comparatorBest standard of care in surgical practice
Receives: Procedure: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NVD-001 (nocc AEs)

    Number of Adverse Events (AEs) severity, relatedness to the product or procedure, required action and outcome, up to 12 months post-surgery

    Measured: 12 months

  2. NVD-001 (npat AEs)

    Number of participants presenting Adverse Events (AEs).

    Measured: 12 months

  3. NVD-001 (nocc SAEs)

    Number of serious Adverse Events (SAEs), severity, relatedness to the product or procedure, required action and outcome.

    Measured: 24 months

  4. NVD-001 (npatSAEs)

    Number of participants presenting Serious Adverse Events (AEs).

    Measured: 24 months

  5. NVD-001 (nocc AESI)

    Number of Adverse Events of Special Interest (AESI) using lumbar spine CT and radiographic images.

    Measured: 24 months

  6. NVD-001 (npat AESI)

    Number of participants with Adverse Events of Special Interest (AESI) using lumbar spine CT and radiographic images.

    Measured: 24 months

  7. NVD-001 (npat Safety X-rays)

    Number of participants with appearance or absence of calcification/ ossification and ectopic bone formation in comparison with preoperative, as determined by chest X-rays.

    Measured: 24 months

  8. NVD-001 (npat Safety Post-Op)

    Number of participants with occurrence or absence of surgical intervention-related safety parameters such as infection and peri- and post-operative blood loss volume

    Measured: 1 month

Secondary outcomes (8)

  1. NVD-001 (LSF)

    Lumbar Spine Fusion progression and non-fusion assessed by serial CT-Scans images of lumbar spine post-surgery and lumbar spine static and dynamic radiographic images.

    Measured: 24 months

  2. NVD-001 (ODI)

    Functional disability by means of Oswestry Disability Index (ODI).

    Measured: 24 months

  3. NVD-001 (BPI)

    Pain by means of Brief Pain Inventory (BPI).

    Measured: 24 months

  4. NVD-001 (OTE)

    Overall treatment effect using OTE scale.

    Measured: 24 months

  5. NVD-001 (QoL)

    Quality of life (QoL) by means of patient's questionnaire EuroQoL 5 Dimensions post-surgery.

    Measured: 24 months

  6. NVD-001 (timeSurgery)

    Surgical duration.

    Measured: 1 day

  7. NVD-001 (stayPostOp)

    Duration of postoperative hospital stay.

    Measured: 7 days

  8. NVD-001 (subsequentSurgery)

    Description of subsequent surgical interventions (revision, removal, reoperation and supplemental fixation).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study startJan 2017
  3. Primary completionJan 2021
  4. Study completionJun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03100032
Sponsor's protocol ID
NVD-CLN01
Other IDs
2016-002642-23, 2016
Acronym
Spine1
Status last verified
Jun 2021
First submitted
8 Feb 2017
Last updated
13 Aug 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Upon study completion, coded data, in European Clinical Trial registry (https://www.clinicaltrialsregister.eu)

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NVD-001 in people with Spondylolisthesis, run by Novadip Biosciences at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Belgium, Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NVD-001 (nocc AEs) (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03100032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in