Early Lumbar Disc DegenerationPhase 1/2NCT01182337
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
A Phase 1/2 study testing Intradiscal rhGDF-5 in people with Early Lumbar Disc Degeneration, run by DePuy Spine at 7 sites in South Korea.
Trial summary
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Lumbar Disc Degeneration
- What is being tested?
- Intradiscal rhGDF-5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Jun 2010to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent low back pain with at least 3 months of non-surgical therapy at one suspected symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized discography protocol. The required discography protocol will be provided by the sponsor. Subjects with multilevel disease must have a provocative discogram confirming that only 1 level is symptomatic at least 2 weeks prior to administration, with an expiry of 12 months from the date performed.
- Oswestry Disability Index (ODI) for low back pain of 30 or greater
- Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
- Male or Female 18 years of age or older
Who cannot join
- Persons unable to have a discogram, CT, or MRI
- Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
- Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
- Extravasation of contrast agent during the discogram into the epidural space (does not include leakage of contrast agent along the needle track or leakage to the outer annular ring at the posterior longitudinal ligament vicinity)
- Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Yeungnam University Medical Center
Daegu
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Korea University Anam Hospital
Seoul
Seoul National University Hospital
Seoul
Seoul St. Mary Hospital
Seoul
Yonsei University Health System
Seoul
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
- Conditions
- Early Lumbar Disc Degeneration
- Being tested
- Intradiscal rhGDF-5, Vehicle control
- 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.
Intradiscal rhGDF-5Drug
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
Vehicle controlDrug
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
| Study group | Role | What they receive |
|---|---|---|
| Intradiscal rhGDF-5 | Experimental | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. Receives: Drug: Intradiscal rhGDF-5 |
| Vehicle control | Placebo comparator | Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection Receives: Drug: Vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Assessment for Motor Function and Reflexes/Sensory
Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.
For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.
For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs.
Measured: 12 months
Treatment Emergent Adverse Events- Relationship to Study Drug
Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.
Measured: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
Treatment Emergent Adverse Events- Relationship to Study Drug
Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.
Measured: 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
Secondary outcomes (4)
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.
The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.
Measured: 12 month
Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.
The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.
Measured: 12 months
Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline
The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).
Measured: 12 months
Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.
The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Lumbar Disc DegenerationStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Korea, Ltd., Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182337
- Sponsor's protocol ID
- 09-Intradiscal rhGDF-5-03
- Status last verified
- Jan 2016
- First submitted
- 11 Aug 2010
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Adoungotchodo A, Epure LM, Mwale F, Lerouge S. Chitosan-based hydrogels supplemented with gelatine and Link N enhance extracellular matrix deposition by encapsulated cells in a degenerative intervertebral disc environment. Eur Cell Mater. 2021 May 4;41:471-484. doi: 10.22203/eCM.v041a30.
PubMed 33945627
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
- ClinicalTrials.gov ID
- NCT01182337
- Acronym / sponsor ID
- 09-Intradiscal rhGDF-5-03
- Conditions
- Early Lumbar Disc Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- DePuy SpineIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Korea, Ltd., Korea
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Posted 27 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradiscal rhGDF-5 | Experimental | Drug: Intradiscal rhGDF-5The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. |
| Vehicle control | Placebo comparator | Drug: Vehicle controlExcipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persistent low back pain with at least 3 months of non-surgical therapy at one suspected symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized discography protocol. The required discography protocol will be provided by the sponsor. Subjects with multilevel disease must have a provocative discogram confirming that only 1 level is symptomatic at least 2 weeks prior to administration, with an expiry of 12 months from the date performed.
- Oswestry Disability Index (ODI) for low back pain of 30 or greater
- Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
- Male or Female 18 years of age or older
Key exclusion criteria (5 listed)
- Persons unable to have a discogram, CT, or MRI
- Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
- Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
- Extravasation of contrast agent during the discogram into the epidural space (does not include leakage of contrast agent along the needle track or leakage to the outer annular ring at the posterior longitudinal ligament vicinity)
- Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments
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 |
|---|---|---|
| Intradiscal rhGDF-5The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. | Drug | Intradiscal rhGDF-5 |
| Vehicle controlExcipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection | Drug | Vehicle control |
Primary outcome
Neurological Assessment for Motor Function and Reflexes/Sensory
Time frame: 12 months
Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs.
Treatment Emergent Adverse Events- Relationship to Study Drug
Time frame: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.
Treatment Emergent Adverse Events- Relationship to Study Drug
Time frame: 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.
4 secondary outcomes
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.
Time frame: 12 month
Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.
Time frame: 12 months
Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline
Time frame: 12 months
Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33945627Adoungotchodo A, Epure LM, Mwale F, Lerouge S. Chitosan-based hydrogels supplemented with gelatine and Link N enhance extracellular matrix deposition by encapsulated cells in a degenerative intervertebral disc environment. Eur Cell Mater. 2021 May 4;41:471-484. doi: 10.22203/eCM.v041a30.
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intradiscal rhGDF-5 in people with Early Lumbar Disc Degeneration, run by DePuy Spine at 7 sites in South Korea.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 27 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neurological Assessment for Motor Function and Reflexes/Sensory (time frame: 12 months). The study lists 3 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 NCT01182337, which also lists 1 linked publication.
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 26 Feb 2016.