ASCEND: et randomiseret, dobbeltblindt, falsk-kontrolleret, multicenter fase I/II klinisk forsøg til evaluering af sikkerheden og effektiviteten af VIA Disc NP, et supplement til degenererede intervertebrale diske (ASCEND)
ASCEND: A Randomized, Double Blind, Sham-Controlled, Multi-Center Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
VIA Disc NP is an off-the-shelf minimally processed human nucleus pulposus tissue allograft intended to supplement degenerated intervertebral discs.
The study is a randomized, double-blind, sham-controlled, multi-center study in participants with symptomatic lumbar intervertebral disc degeneration (> 6 months) and unresponsive to conservative therapy for at least 3 months. Participants will be randomized on a 1:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or a sham procedure at 1 or 2 levels.
Participants who consent to participate in the study and meet all eligibility criteria during the Screening/Baseline period will return on Day 1 to be randomized to either the VIA Disc NP or sham-control group. At 12-weeks post-treatment, participants allocated to the sham-control group will be given the option to crossover to the VIA Disc NP group if they meet the requirement to crossover.
All participants will be followed through 52-weeks post-treatment at which time they will be asked if they would like to consent to participate in an extended long-term follow-up period. The sham-control group participants who did not crossover at 12-weeks will be exited from the study at this visit. If participants consent to participate in the extended long-term follow-up period, the VIA Disc NP group will be followed through 24-Months and the sham-control group will be followed through 27-months. If the participant declines participation, they will be exited from the study at this visit.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New South Wales
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Broadmeadow, New South Wales, Australien, 2292
- Genesis Research Services Pty Ltd
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Hurstville, New South Wales, Australien, 2220
- Australian Medical Research
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Wahroonga, New South Wales, Australien, 2076
- Sydney Pain Research Centre
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South Australia
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Wayville, South Australia, Australien, 5034
- Cercare Clinical Research
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Victoria
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Clayton, Victoria, Australien, 3168
- Monash House Research Centre Pty Ltd
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Key Inclusion Criteria:
- Age 22 to 85 years old
- Diagnosis of early to moderate DDD, Modified Pfirrmann Grade 3-7
- Chronic axial midline low-back pain with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
- Positive hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening
- Demonstrated intolerance to sitting for more than 30 minutes at a time based on self-report or assessed by a qualified healthcare professional at the screening visit
- Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS at the time of Screening
- ODI score of ≥ 40 to ≤ 80 at the time of Screening
Key Exclusion Criteria:
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Contraindication to MRI for any reason
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Contraindications to the proposed sedation/anesthetic protocol
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Symptomatic involvement of more than two lumbar discs
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Fracture of the lumbar spine, previous lumbar spine surgery or previous treatment of the target disc(s)
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Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
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Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology
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Clinical suspicion of facet pain as primary pain generator
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Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study. Pregnancy is confirmed by:
- A positive pregnancy test during the screening visit
- Self-reported pregnancy
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Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Sham-komparator: Sham Arm
|
Participants will receive the sham procedure at 1 or 2 levels. The procedure will be identical to the investigational procedure with the following exception: A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. |
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Aktiv komparator: VIA Disc NP
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Participants will receive a single dose, intradiscal injection of 100 mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered to the affected level(s), L1-S1 (1 or 2 levels). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.
Tidsramme: Baseline to 26 Weeks
|
A comparison of the proportion of participants who show a minimally clinically important difference (MCID), defined as at least a 30% reduction in back pain VAS score from baseline to 26 weeks (6 months), in the VIA Disc NP group to that in the sham-control group. |
Baseline to 26 Weeks
|
|
Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 12 weeks
Tidsramme: Baseline to 12 weeks
|
The proportion of participants that experience one or more treatment-related (including procedure) adverse events in the VIA Disc NP group compared to the sham-control group at 12 weeks (3 months) as determined by the Principal Investigator. |
Baseline to 12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VIA-2024-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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