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A Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of IDCT In Subjects With Single-Level, Symptomatic Mild To Moderate Lumbar Intervertebral Disc Degeneration
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks).
The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening.
Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham.
Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date.
Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio.
* IDCT (n=108)
* Sham (n=54)
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A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study To Assess The Safety And Efficacy Of SL1002 Injectable For The Treatment Of Knee Pain In Patients With Osteoarthritis Of The Knee
Rochester, Minn.
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.
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