Degenerative Disc DiseaseNCT02379689
Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two Level, Symptomatic Lumbar Intervertebral Disc Degeneration
A study testing Injectable placental tissue extract called BioDGenesis (Active Product) in people with Degenerative Disc Disease and Pain, run by Semmes-Murphey Foundation at 1 site in United States.
Trial summary
Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease, Pain
- What is being tested?
- Injectable placental tissue extract called BioDGenesis (Active Product)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subject must be ≥18 and ≤75 years of age, skeletally mature, and have a BMI ≥18 kg/m2 and ≤30 kg/m2 at Screening.
- The subject must have been experiencing low back pain for at least 6 months prior to Screening.
- The subject must have had low back pain that is unresponsive to at least 3 months of conservative care (non operative treatment), which may include bed rest, anti inflammatory or analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise programs.
- The subject must have pretreatment (Baseline) low back pain of 30 to 90 mm on the visual analog scale (VAS) at Screening and Baseline.
- The subject must have pretreatment (Baseline) Oswestry Disability Index Questionnaire (ODI) score of 30 to 70 points at Screening and Baseline.
- The subject's target disc must meet the following objective criteria (corresponding to Pfirrman Grade 2 and 3):
- The subject must be willing to voluntarily sign the informed consent form and agree to the release of medical information for purposes of this study (i.e., HIPAA authorization) at Screening.
- The subject must be physically and mentally able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol.
Who cannot join
- The subject has radiculopathy resulting from nerve compression at Screening or Baseline.
- The subject has unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low back pain as measured on a VAS at Screening or Baseline.
- The subject has cauda equina syndrome at Screening or Baseline (Day 1).
- The subject has greater than 50% loss of disc height when compared to the adjacent superior disc.
- The subject has a significant disc herniation or free fragment of disc material on MRI.
- The subject has current infection at the planned procedure site, active systemic infection, or current or prior history of lumbar spinal infection (i.e., discitis, septic arthritis, epidural abscess) at Baseline.
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- The subject has had previous lumbar spine surgery.
- The subject has had previous disc treatment procedures or intradiscal injections. Discography may have been performed, but the procedure must have been done at least 2 weeks or more prior to the injection of study medication.
- The subject has undergone lumbar epidural or transforaminal injections with corticosteroids within the last 3 months.
- The subject has evidence of prior lumbar vertebral body fracture or trauma.
- The subject has evidence of dynamic instability on lumbar flexion extension.
- The subject has Grade 2 or higher spondylolisthesis or spondylolysis at the target disc at Screening.
- The subject has findings of a significant underlying neurological condition (motor strength <4; sensory assessment abnormal; or reflexes absent or hyperactive with clonus).
- The subject has an active malignancy or tumor.
- The subject has had significant systemic disease, such as unstable angina, autoimmune disease, rheumatoid arthritis, diabetes mellitus, or muscular dystrophy.
- The subject has a coagulopathy or thrombocytopenia.
- The subject is currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia inducing medications (except for aspirin or nonsteroidal anti-inflammatory drugs [NSAIDS]) at Baseline.
- The subject is taking opioid analgesics regularly more than 2 times per day, or taking long acting or long term opioids for more than 90 days at Baseline.
- The subject has concomitant conditions requiring daily oral steroid usage for more than 30 days in the preceding 90 days before Screening.
- The subject has a history of unexplained, easy, or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures.
- The subject has a history of hypersensitivity or anaphylactic reaction to bovine products, HA, or dimethyl sulfoxide (DMSO).
- The subject is currently using tobacco or has actively used tobacco within 3 months prior to enrollment.
- The subject has an uncontrolled psychiatric condition or substance/alcohol abuse that would potentially interfere with the subject's participation in the study within 2 years prior to Screening.
- The subject has participated in another drug or device clinical study within the 2 months immediately prior to Screening.
- The subject is known to be pregnant or nursing at time of enrollment or with plans to become pregnant within the planned length of the study.
- The subject has pending litigation against a health care professional or other pending civil litigation, except where required by the insurer as a condition of coverage.
- The subject has active or pending worker's compensation claims.
- The subject has a body habitus that precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible.
- The subject has a contraindication to MRI scanning or cannot tolerate MRI scanning.
- -
Trial locations and contacts
1 site in 1 country.
Autry Parker, M.D. contact
United States1 site, 1 recruiting
- Recruiting
Western Institutional Review Board® (WIRB®)
Puyallup, Washington, Washington, 98374-2115
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled With Crossover Study to Evaluate the Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two Level, Symptomatic Lumbar Intervertebral Disc Degeneration
Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human tissue, that will be injected into the affected disc. With this study, the investigators hope to find a safe and effective way to treat degenerative disc disease.
Read the detailed description
Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human tissue, that will be injected into the affected disc. With this study, we hope to find a safe and effective way to treat degenerative disc disease.
This study will compare injectable placental tissue extract called BioDGenesis ("Active Product") to injectable Normal Saline ("Placebo"). The Active Product is supplied by BioD, LLC ("BioD"). You have a 50 percent chance of receiving the Placebo
The study will last for 52 weeks. After all patients have been enrolled in the study and have completed 26 weeks, the Investigator will conduct a safety and efficacy analysis. If the investigator determines that the Active Product is more effective than Placebo in treating degenerative disc disease and there are no safety concerns with the Active Product, patients who received Placebo will have the option of receiving the Active Product through week 52.
- Conditions
- Degenerative Disc Disease, Pain
- Being tested
- Injectable placental tissue extract called BioDGenesis (Active Product), Placebo
- Keywords
- psychosocial state
- Medical subject headings
- Intervertebral Disc Degeneration, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable placental tissue extract called BioDGenesis (Active Product)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| injectable placental tissue extract called BioDGenesis | Active comparator | This study will compare injectable placental tissue extract called BioDGenesis (Active Product) Receives: Drug: Injectable placental tissue extract called BioDGenesis (Active Product) |
| Placebo | Placebo comparator | injectable Tissue Suspension Solution (TSS) (Placebo). The Active Product is supplied by BioD, LLC (BioD). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract (IPE) on lower back pain (VAS).
Measured: 52 weeks
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on disability (ODI).
Measured: 52 weeks
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on quality of life (EQ-5D).
Measured: 52 weeks
Secondary outcomes (1)
• Composite outcome measure: Change from baseline and compared to Tissue Suspension Solution in qualitative assessments
- Composite outcome measure: Change from baseline and compared to Tissue Suspension Solution in qualitative assessments associated with MRI imaging (T2-weighted image), including Pfirrman score, modic changes, annular tears/fissures, endplate integrity, herniation and additional observations at 12 weeks of treatment.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmes-Murphey Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379689
- Sponsor's protocol ID
- Parker 1001
- Status last verified
- Nov 2015
- First submitted
- 24 Feb 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled With Crossover Study to Evaluate the Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two Level, Symptomatic Lumbar Intervertebral Disc Degeneration
- ClinicalTrials.gov ID
- NCT02379689
- Acronym / sponsor ID
- Parker 1001
- Conditions
- Degenerative Disc Disease, Pain
- Keywords
- psychosocial state
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Semmes-Murphey FoundationUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 5 Mar 2015 (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.
Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human tissue, that will be injected into the affected disc. With this study, the investigators hope to find a safe and effective way to treat degenerative disc disease.
Detailed description
Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human tissue, that will be injected into the affected disc. With this study, we hope to find a safe and effective way to treat degenerative disc disease.
This study will compare injectable placental tissue extract called BioDGenesis ("Active Product") to injectable Normal Saline ("Placebo"). The Active Product is supplied by BioD, LLC ("BioD"). You have a 50 percent chance of receiving the Placebo
The study will last for 52 weeks. After all patients have been enrolled in the study and have completed 26 weeks, the Investigator will conduct a safety and efficacy analysis. If the investigator determines that the Active Product is more effective than Placebo in treating degenerative disc disease and there are no safety concerns with the Active Product, patients who received Placebo will have the option of receiving the Active Product through week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injectable placental tissue extract called BioDGenesis | Active comparator | Drug: Injectable placental tissue extract called BioDGenesis (Active Product)This study will compare injectable placental tissue extract called BioDGenesis (Active Product) |
| Placebo | Placebo comparator | Drug: Placeboinjectable Tissue Suspension Solution (TSS) (Placebo). The Active Product is supplied by BioD, LLC (BioD). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- The subject must be ≥18 and ≤75 years of age, skeletally mature, and have a BMI ≥18 kg/m2 and ≤30 kg/m2 at Screening.
- The subject must have been experiencing low back pain for at least 6 months prior to Screening.
- The subject must have had low back pain that is unresponsive to at least 3 months of conservative care (non operative treatment), which may include bed rest, anti inflammatory or analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise programs.
- The subject must have pretreatment (Baseline) low back pain of 30 to 90 mm on the visual analog scale (VAS) at Screening and Baseline.
- The subject must have pretreatment (Baseline) Oswestry Disability Index Questionnaire (ODI) score of 30 to 70 points at Screening and Baseline.
Key exclusion criteria (30 listed)
- The subject has radiculopathy resulting from nerve compression at Screening or Baseline.
- The subject has unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low back pain as measured on a VAS at Screening or Baseline.
- The subject has cauda equina syndrome at Screening or Baseline (Day 1).
- The subject has greater than 50% loss of disc height when compared to the adjacent superior disc.
- The subject has a significant disc herniation or free fragment of disc material on MRI.
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 |
|---|---|---|
| Injectable placental tissue extract called BioDGenesis (Active Product) | Drug | injectable placental tissue extract called BioDGenesis |
| Placebo | Drug | Placebo |
Primary outcome
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract (IPE) on lower back pain (VAS).
Time frame: 52 weeks
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on disability (ODI).
Time frame: 52 weeks
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on quality of life (EQ-5D).
Time frame: 52 weeks
1 secondary outcome
• Composite outcome measure: Change from baseline and compared to Tissue Suspension Solution in qualitative assessments
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Autry Parker, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable placental tissue extract called BioDGenesis (Active Product) in people with Degenerative Disc Disease and Pain, run by Semmes-Murphey Foundation at 1 site 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 8 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Autry Parker, M.D. ((901) 259-5324), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract (IPE) on lower back pain (VAS). (time frame: 52 weeks). 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?
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 17 Nov 2015.