Degenerative Disc DiseasePhase 2ASCENDNCT06615505

ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs

A Phase 2 study testing VIA Disc NP in people with Degenerative Disc Disease and Disc Degeneration, run by VIVEX Biologics, Inc. at 5 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 22 to 85 years
Conditions the study is for: Degenerative Disc Disease, Disc Degeneration, Lumbar Discogenic Pain
What is being tested?: VIA Disc NP
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 5 sitesAustralia
Study dates: 4 Oct 2024to Nov 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 22 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Contraindication to MRI for any reason
Contraindications to the proposed sedation/anesthetic protocol
Symptomatic involvement of more than two lumbar discs
Fracture of the lumbar spine, previous lumbar spine surgery or previous treatment of the target disc(s)
Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology

Show all 11Show fewer

Clinical suspicion of facet pain as primary pain generator
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
Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Australia5 sites

Genesis Research Services Pty Ltd
Broadmeadow, New South Wales, 2292
Monash House Research Centre Pty Ltd
Clayton, Victoria, 3168
Australian Medical Research
Hurstville, New South Wales, 2220
Sydney Pain Research Centre
Wahroonga, New South Wales, 2076
Cercare Clinical Research
Wayville, South Australia, 5034

Other trials in Australia

About this study

Official 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

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.

Conditions: Degenerative Disc Disease, Disc Degeneration, Lumbar Discogenic Pain
Being tested: VIA Disc NP, Sham Injection
Keywords: Degenerative Disc Disease, Lumbar Discogenic Pain
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

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

VIA Disc NPOther
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).
Sham InjectionOther
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.

Study groups in NCT06615505
Study group	Role	What they receive
VIA Disc NP	Active comparator	Not described Receives: Other: VIA Disc NP
Sham Arm	Sham comparator	Not described Receives: Other: Sham Injection

What is being measured

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

Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from 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.
Measured: Baseline to 26 Weeks
Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 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.
Measured: Baseline to 12 weeks

Timeline

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

4 Oct 2024Nov 2027

First posted26 Sep 2024
Study start4 Oct 2024
Primary completion6 Feb 2026
Study completionNov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: At the 12-week follow-up, all participants will remain blinded and will be given the option to be considered for crossover. Only participants allocated to the needle sham control group will be given the option to crossover into the VIA Disc NP group at the 12-week visit if they meet the following requirement: The participant has not experienced at least a 30% reduction in pain severity as determined by their 12-week VAS score Sham participants who crossover into the VIA Disc NP group will receive an injection of VIA Disc NP and continue in the study.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06615505
Sponsor's protocol ID: VIA-2024-001
Acronym: ASCEND
Status last verified: Oct 2026
First submitted: 24 Sep 2024
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Not yet recruiting
Lumbar Fusion With Nanotube Versus Titanium Cage
Degenerative Disc Disease, Lumbar Fusion
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT06615505
Acronym / sponsor ID: ASCEND / VIA-2024-001
Conditions: Degenerative Disc Disease, Disc Degeneration, Lumbar Discogenic Pain
Keywords: Degenerative Disc Disease, Lumbar Discogenic Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 121 participants (actual)
Lead sponsor: VIVEX Biologics, Inc.Industry (pharma, biotech, devices)
Study start: 4 Oct 2024 (actual)
Primary completion: 6 Feb 2026 (actual)
Study completion: Nov 2027 (estimated)
First posted: 26 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

VIA Disc NP is an off-the-shelf minimally processed human nucleus pulposus tissue allograft intended to supplement degenerated intervertebral discs.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: At the 12-week follow-up, all participants will remain blinded and will be given the option to be considered for crossover. Only participants allocated to the needle sham control group will be given the option to crossover into the VIA Disc NP group at the 12-week visit if they meet the following requirement: The participant has not experienced at least a 30% reduction in pain severity as determined by their 12-week VAS score Sham participants who crossover into the VIA Disc NP group will receive an injection of VIA Disc NP and continue in the study.

Arm	Type	Receives
VIA Disc NP	Active comparator	Other: VIA Disc NP
Sham Arm	Sham comparator	Other: Sham Injection

Who may qualify

Ages: 22 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

Contraindication to MRI for any reason
Contraindications to the proposed sedation/anesthetic protocol
Symptomatic involvement of more than two lumbar discs
Fracture of the lumbar spine, previous lumbar spine surgery or previous treatment of the target disc(s)
Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VIA Disc NPParticipants 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	VIA Disc NP
Sham InjectionParticipants 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.	Other	Sham Arm

Primary outcome

Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.
Time frame: 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.
Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 12 weeks
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Degenerative Disc Disease

Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Not yet recruiting
Lumbar Fusion With Nanotube Versus Titanium Cage
Degenerative Disc Disease, Lumbar Fusion
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIA Disc NP in people with Degenerative Disc Disease and Disc Degeneration, run by VIVEX Biologics, Inc. at 5 sites in Australia.

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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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?

Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks. (time frame: Baseline to 26 Weeks). The study lists 2 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 NCT06615505.

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 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.