Degenerative Disc DiseasePhase 2NCT01771471
A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
A Phase 2 study testing NuQu in people with Degenerative Disc Disease, run by ISTO Technologies, Inc. at 10 sites in United States.
Trial summary
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- NuQu
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2012to Sep 2020
- Phase
- Phase 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
- Is at least 21 years of age;
- Have central low back pain aggravated by movement and or postural changes (standing/sitting);
- Have had back pain for at least 6 months, and have failed conservative management
- One Grade III or IV (Pfirrmann Scale) degenerated lumbar disc;
Who cannot join
- Current disc extrusion at any level in their lumbar spine; disc bulges or protrusions at any level in the lumbar spine resulting in nerve root compression;
- Severe disc narrowing (equal to or more than 50% loss of disc height at the targeted level);
- Type II or III Modic changes at any level;
- Type I Modic changes at any level other than the targeted level;
- Type I Modic changes at the treated level if maximum height of the changes is 25% or more of the vertebral body height;
- Osteoporotic compression fracture at any vertebral level;
Show all 18Show fewer
- Lumbar Scheurmann's disease;
- Antero or retrolisthesis ≥ 3mm at any level;
- Currently experiencing chronic pain generating from any other source, which (in the judgment of the investigator) may interfere with the evaluation of back pain, and or disability;
- Infection at the planned treatment site, history of systemic or local infection, which (in the investigator's judgment) may compromise subject participation and/or safety;
- Currently diagnosed with immune-deficiency, which in the investigator's opinion may compromise subject participation and/or safety;
- Receiving any immune-suppressant therapies other than short term steroid preparations;
- BMI≥40;
- Diagnosed with any comorbid conditions including: abnormal bleeding, AIDS, diabetes, hepatic or renal disease, and cardiopulmonary disorders such as COPD, MI and CHF; active malignancy or history of malignancy, or diseases of bone metabolism, which in the investigator's opinion may compromise subject participation and/or safety;
- Has a history of alcoholism, medication or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or 3 or more Waddell Signs of nonorganic Behavior or any combination of variables in the Investigator's judgment that should exclude a potential subject;
- Has pending litigation against a health care professional, except where required by the insurer as a condition of coverage, personal injury compensation or litigation claims;
- Has active or pending workers' compensation claims;
- Has contraindications for MRI.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Alabama Orthopedic and Spine Center
Birmingham, Alabama, 35235
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204
The NeuroSpine Institute
Eugene, Oregon, 79401
Ortho Georgia
Macon, Georgia, 31210
Weill Cornell Medical College
New York, New York, 10065
Tufts University School of Medicine
Newton, Massachusetts, 02458
Spinal Reseach Foundation
Reston, Virginia, 20190
California Spine Diagnostics
San Francisco, California, 94115
The Spine Institute, Center for Spinal Restoration
Santa Monica, California, 90403
Spine Team Texas
Southlake, Texas, 76092
About this study
Official title: A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
Read the detailed description
This is a Phase II clinical study to collect additional safety data and preliminary efficiency of juvenile chondrocytes, delivered in fibrin carrier (NuQu®) to the nucleus of lumbar intervertebral discs for the treatment of discogenic pain. This to be accomplished through a double blinded, placebo-controlled study of clinically meaningful endpoints including validated, subject reported outcomes of pain and disability, health related quality of life and subject satisfaction with treatment.
- Conditions
- Degenerative Disc Disease
- Being tested
- NuQu, Placebo
- Keywords
- back pain, intervertebral disc, lumbar spine
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuQuBiological
Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.
PlaceboOther
0.9% w/v Sodium Chloride for Injection, USP
| Study group | Role | What they receive |
|---|---|---|
| NuQu treatment | Experimental | single administration Receives: Biological: NuQu |
| Saline | Other | single administration Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Measured: 12 months
Secondary outcomes (3)
Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition
Success to be measured by the response of "Definitely True" or "Mostly True" to the following: "All things considered I would have the treatment again for the same condition".
Measured: 24 Months
MRI
Measured: 24 Months
Visual Analog Scale
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Change in clinical strategy
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISTO Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Domagoj Coric, MD, Principal investigator, Carolina Neurosurgery and Spine Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771471
- Sponsor's protocol ID
- ISTO-NUQ02-10-12-00
- Status last verified
- Sep 2016
- First submitted
- 14 Jan 2013
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes
- ClinicalTrials.gov ID
- NCT01771471
- Acronym / sponsor ID
- ISTO-NUQ02-10-12-00
- Conditions
- Degenerative Disc Disease
- Keywords
- back pain, intervertebral disc, lumbar spine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in clinical strategy
- Enrolment
- 44 participants (actual)
- Lead sponsor
- ISTO Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 18 Jan 2013 (estimated)
- 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.
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
Detailed description
This is a Phase II clinical study to collect additional safety data and preliminary efficiency of juvenile chondrocytes, delivered in fibrin carrier (NuQu®) to the nucleus of lumbar intervertebral discs for the treatment of discogenic pain. This to be accomplished through a double blinded, placebo-controlled study of clinically meaningful endpoints including validated, subject reported outcomes of pain and disability, health related quality of life and subject satisfaction with treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuQu treatment | Experimental | Biological: NuQusingle administration |
| Saline | Other | Other: Placebosingle administration |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
- Is at least 21 years of age;
- Have central low back pain aggravated by movement and or postural changes (standing/sitting);
- Have had back pain for at least 6 months, and have failed conservative management
- One Grade III or IV (Pfirrmann Scale) degenerated lumbar disc;
Key exclusion criteria (18 listed)
- Current disc extrusion at any level in their lumbar spine; disc bulges or protrusions at any level in the lumbar spine resulting in nerve root compression;
- Severe disc narrowing (equal to or more than 50% loss of disc height at the targeted level);
- Type II or III Modic changes at any level;
- Type I Modic changes at any level other than the targeted level;
- Type I Modic changes at the treated level if maximum height of the changes is 25% or more of the vertebral body height;
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 |
|---|---|---|
| NuQuAllogenic juvenile chondrocytes (NuQu) in fibrin carrier. | Biological | NuQu treatment |
| Placebo0.9% w/v Sodium Chloride for Injection, USP | Other | Saline |
Primary outcome
Oswestry Disability Index
Time frame: 12 months
3 secondary outcomes
Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition
Time frame: 24 Months
MRI
Time frame: 24 Months
Visual Analog Scale
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: Change in clinical strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
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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.
Domagoj Coric, MD principal investigator
Carolina Neurosurgery and Spine Associates
10 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 NuQu in people with Degenerative Disc Disease, run by ISTO Technologies, Inc. at 10 sites in United States.
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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 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?
The study was stopped early (reason given: Change in clinical strategy). Results are not available in the source record.
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?
Oswestry Disability Index (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2017.