ASCEND: ensayo clínico de fase I/II multicéntrico, aleatorizado, doble ciego, controlado de forma simulada para evaluar la seguridad y eficacia de VIA Disc NP, un suplemento para discos intervertebrales degenerados (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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New South Wales
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Broadmeadow, New South Wales, Australia, 2292
- Genesis Research Services Pty Ltd
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Hurstville, New South Wales, Australia, 2220
- Australian Medical Research
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Wahroonga, New South Wales, Australia, 2076
- Sydney Pain Research Centre
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South Australia
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Wayville, South Australia, Australia, 5034
- Cercare Clinical Research
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash House Research Centre Pty Ltd
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador falso: Brazo simulado
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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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Comparador activo: A través del disco 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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.
Periodo de tiempo: Baseline to 26 Weeks
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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
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Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 12 weeks
Periodo de tiempo: Baseline to 12 weeks
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VIA-2024-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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