What side effects are associated with this type of intervention?

Common treatments for pain, such as prolotherapy and corticosteroid injections, have known side effects. Prolotherapy can cause temporary increases in back pain, stiffness, and post-injection headaches. Corticosteroid injections may lead to increased pain, transient lower limb numbness, paraesthesias, and superficial burns. Interventional therapies like radiofrequency denervation can also result in increased pain and transient numbness. These side effects are typically temporary but should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved various injectable treatments for pain management, including glucocorticoid injections for joint and soft tissue pain, and epidural steroid injections for radicular pain. Platelet-rich plasma (PRP) injections, although not routinely recommended, are used for certain musculoskeletal conditions. Investigational agents like disease-modifying antirheumatic drugs (DMARDs) have shown mixed results in clinical trials. While specific FDA approvals for human tissue-derived product injections for degenerative disc disease are not detailed, these regenerative and interventional approaches represent a growing area of interest in pain management.

What other types of research exist?

Promising novel alternatives to human tissue-derived product injections for the regeneration and repair of degenerated disc tissue include: 1) Enzymatically cross-linked composite collagen-hyaluronan scaffolds, which provide a stable structure for cell growth and show potential for injectable cell-seeded scaffolds. 2) Stem cell therapies, although current evidence for their efficacy in tendon disorders is limited, they hold potential for disc regeneration. Patients should discuss these options with their healthcare provider to determine the best course of action based on the latest research and individual health needs.

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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

Must not have

Subject has an active malignancy or tumor

Subject has a history of bleeding problems

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Summary

This trial is testing an injection made from human placental tissue to treat patients with degenerative disc disease. The goal is to see if this new treatment can help repair and regenerate damaged discs in the spine, reducing pain and improving function.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an active cancer.

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I have a history of bleeding issues.

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I have nerve pain due to compression.

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My leg pain is more intense than my lower back pain.

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My MRI shows I have a significant disc herniation or a piece of disc material has broken free.

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I do not have any infections, especially at the site of my upcoming procedure or in my spine.

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I have had surgery on my lower back before.

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I have had treatments or injections for my spinal disc before.

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I have a serious brain or nerve condition.

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I have a blood clotting disorder or low platelet count.

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I have been taking opioids regularly for pain more than twice daily or long-term for over 90 days.

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I have been taking daily oral steroids for more than 30 days in the last 3 months.

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I have had a previous fracture or injury in my lower back.

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I have been diagnosed with cauda equina syndrome.

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I am currently on medication.

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I have had a lumbar spine injection with steroids in the last 3 months.

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I have a moderate to severe spinal condition at the target disc.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

• 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).

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pain, especially those involving injections and biologic therapies, include platelet-rich plasma (PRP) injections, autologous whole blood injections, and cellular therapies such as mesenchymal stem cells (MSCs). These treatments work by delivering high concentrations of growth factors, cytokines, and cells directly to the site of injury, promoting tissue repair and modulating inflammation. For pain patients, particularly those with conditions like degenerated disc tissue, these mechanisms are crucial as they offer potential for not just symptom relief but also tissue regeneration and long-term healing, addressing the underlying cause of pain rather than just masking it.

A new approach to the treatment of chronic low back pain.Central Nervous System Targets: Supraspinal Mechanisms of Analgesia.The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.