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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06615505




Registration number
NCT06615505
Ethics application status
Date submitted
24/09/2024
Date registered
26/09/2024
Date last updated
3/10/2024

Titles & IDs
Public title
ASCEND: a Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Scientific title
ASCEND: a Randomized, Double Blind, Sham-Controlled, Multi-Center Phase I/II Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Secondary ID [1] 0 0
VIA-2024-001
Universal Trial Number (UTN)
Trial acronym
ASCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disc Disease 0 0
Disc Degeneration 0 0
Lumbar Discogenic Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VIA Disc NP
Other interventions - Sham Injection

Active comparator: VIA Disc NP -

Sham comparator: Sham Arm -


Other interventions: VIA Disc NP
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).

Other interventions: Sham Injection
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.
Timepoint [1] 0 0
Baseline to 26 Weeks
Primary outcome [2] 0 0
Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 12 weeks
Timepoint [2] 0 0
Baseline to 12 weeks

Eligibility
Key inclusion criteria
Key

1. Age 22 to 85 years old
2. Diagnosis of early to moderate DDD, Modified Pfirrmann Grade 3-7
3. 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
4. Positive hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening
5. 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
6. Low-back pain severity score of = 40 to = 90 mm on the VAS at the time of Screening
7. ODI score of = 40 to = 80 at the time of Screening

Key
Minimum age
22 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication to MRI for any reason
2. Contraindications to the proposed sedation/anesthetic protocol
3. Symptomatic involvement of more than two lumbar discs
4. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc(s)
5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology
7. Clinical suspicion of facet pain as primary pain generator
8. 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
9. Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Clinical Research Pty Ltd - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
VIVEX Biologics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06615505
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stuart Pratt
Address 0 0
Country 0 0
Phone 0 0
901-238-5834
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06615505