Is NCT06778447 recruiting in New Castle, IN?

Yes, NCT06778447 is currently recruiting participants at its New Castle, IN location. This degenerative disc disease clinical trial is actively enrolling qualified participants.

How do I join the degenerative disc disease clinical trial in New Castle?

To join this clinical trial in New Castle, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Castle clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Degenerative Disc Disease Clinical Trial in New Castle, IN

About This Degenerative Disc Disease Study in New Castle

VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.

Sponsor: VIVEX Biologics, Inc.

Who Can Participate

Inclusion Criteria

Age 22 to 85 years old

Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7

Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care

Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS

ODI score of ≥ 40 to ≤ 80

Positive sustained hip flexion test

Demonstrated intolerance to sitting

Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study

Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years

Exclusion Criteria

Contraindications to the proposed sedation/anesthetic protocol

Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater

Disc height of less than 4mm for any disc between L1-S1

Symptomatic vertebral compression fracture

Previous surgical treatment of the lumbar spine

History of sacroiliac (SI) joint fusion within the past six months

Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, provocative or anesthetic discography, SI joint pain injection, injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure

Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)

Received prior intradiscal stem cell/progenitor cell therapy or other biological intervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0 procedure

Evidence of dynamic instability on lumbar flexion-extension radiographs (\>3 mm)

Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes adjacent to the target disc

Radiographic evidence of a full thickness annular tear at the target disc or other abnormal disc morphology

Clinical suspicion of facet pain as primary pain generator

A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, recent history of myocardial infarction, uncontrolled diabetes (\>7.0% HbA1C), etc.)

Received VIA Disc NP previously.

Deemed unsuitable for clinical study participation by the Investigator

Evidence of substance abuse (including marijuana); note: subjects using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within the 3 months prior to screening and subjects on long-acting opioids may be given option to wean off opiates before enrollment; subjects on short-acting opiates (e.g., hydrocodone, oxycodone, tramadol, etc.) may be included and utilization monitored after the treatment

Opioid use of more than 90 MME/day

Currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd, or inhalation steroids for asthma is allowed)

Metal or ceramic implants in the lumbar spine region

Contraindications to MRI, including non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.

Involved in ongoing or closed (within 6 months of screening visit) litigation related to their back pain condition

Any mental instability, unstable bipolar disorders, unmanaged post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression and/or require new or changed anti-depressants or anti-psychotic medications within 3 months of enrollment

Diagnosis of any traumatic neurological disorders that may impact the study as per the judgement of the Investigator

Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study; pregnancy is confirmed by:

a positive pregnancy test during the screening visit

self-reported pregnancy

Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)

Received any experimental drug or device to treat the same condition used within 6 months prior to the screening visit or during the course of the clinical trial

Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Castle?

Yes, this clinical trial (NCT06778447) has an active research site in New Castle, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Degenerative Disc Disease Treatment Options in New Castle, IN

If you're searching for degenerative disc disease treatment options in New Castle, IN, this clinical trial (NCT06778447) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Castle research site is actively enrolling participants for this clinical trial. You'll receive care from experienced degenerative disc disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all degenerative disc disease clinical trials near you to find additional studies recruiting in your area.

Degenerative Disc Disease Clinical Trial in New Castle, IN

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