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Biological
Placental Tissue Extract Injection for Degenerative Disc Disease
N/A
Waitlist Available
Research Sponsored by Semmes-Murphey Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject's target disc must meet the objective criteria corresponding to Pfirrman Grade 2 and 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial will test a new potential treatment for degenerative disc disease, by injecting a product derived from human tissue into the affected disc. The goal is to find a safe and effective way to treat the condition.
Who is the study for?
Adults aged 18-75 with a BMI of 18-30 kg/m2, suffering from low back pain for at least 6 months despite trying non-surgical treatments like medications or physical therapy. Participants must have moderate disability and pain levels, and be able to follow the study's procedures. Excluded are pregnant individuals, those in other studies recently, with certain back conditions (like nerve compression), pending lawsuits related to health care, infections at the injection site or history of spinal infection, significant disc herniation or instability in their spine.Check my eligibility
What is being tested?
The trial is testing BioDGenesis—a placental tissue extract injected into degenerated discs—against a placebo. The goal is to determine if this treatment can safely reduce pain and improve function in patients with lumbar intervertebral disc degeneration.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, allergic responses especially in those sensitive to bovine products or components of the injectable material. There might also be risks associated with MRI procedures required by the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal disc condition is moderately degenerated.
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I can follow the study's requirements and fill out the needed forms.
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My lower back pain scores between 30 to 90 on a pain scale.
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I am between 18 and 75 years old, fully grown, and my BMI is between 18 and 30.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract (IPE) on lower back pain (VAS).
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on disability (ODI).
• To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on quality of life (EQ-5D).
Secondary outcome measures
• Composite outcome measure: Change from baseline and compared to Tissue Suspension Solution in qualitative assessments
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: injectable placental tissue extract called BioDGenesisActive Control1 Intervention
This study will compare injectable placental tissue extract called BioDGenesis (Active Product)
Group II: PlaceboPlacebo Group1 Intervention
injectable Tissue Suspension Solution (TSS) (Placebo). The Active Product is supplied by BioD, LLC (BioD).
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Who is running the clinical trial?
Semmes-Murphey FoundationLead Sponsor
2 Previous Clinical Trials
1,140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old, with a BMI between 18 and 30.I currently have an active cancer.My spinal disc condition is moderately degenerated.I have had low back pain for over 3 months that hasn't improved with non-surgical treatments.I can follow the study's requirements and fill out the needed forms.I have had low back pain for over 3 months that didn't improve with standard non-surgical treatments.You have a baseline ODI score of 30 to 70 pointsI can follow the study's requirements and fill out necessary forms.I have a history of bleeding issues.My lower back pain scores between 30 to 90 on a pain scale.I have nerve pain due to compression.My leg pain is more intense than my lower back pain.I am between 18 and 75 years old, fully grown, and my BMI is between 18 and 30.I have had surgery on my lower back before.I have had treatments or injections for my spinal disc before.I have a serious brain or nerve condition.I have a blood clotting disorder or low platelet count.I have been taking opioids regularly for pain more than twice daily or long-term for over 90 days.I have been taking daily oral steroids for more than 30 days in the last 3 months.My MRI shows I have a significant disc herniation or a piece of disc material has broken free.I do not have any infections, especially at the site of my upcoming procedure or in my spine.My lower back pain scores between 30 to 90 on the pain scale.I have had low back pain for at least 6 months.I have had low back pain for at least 6 months.I have had a previous fracture or injury in my lower back.I have been diagnosed with cauda equina syndrome.I am currently on medication.I have had a lumbar spine injection with steroids in the last 3 months.I have a moderate to severe spinal condition at the target disc.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: injectable placental tissue extract called BioDGenesis
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being enrolled in this trial?
"Although this particular trial is not taking on any more patients, there are 435 other clinical trials with open enrollment. The study in question was first posted December 1st, 2014 and last updated November 16th, 2015 according to the website clinicaltrials.gov"
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
Illinois
How old are they?
18 - 65
What site did they apply to?
Western Institutional Review Board® (WIRB®)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have applied to this trial because no other treatment works for more than a day or so, primarily pain medication or chiropractic manipulation therapy.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
When this trial likely start?
PatientReceived no prior treatments
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