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Chronic discogenic lower back pain - Healing Genes
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Chronic discogenic lower back pain

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AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain

A Phase 1b, Multicenter, Double-blind, Randomized, Placebo-controlled, Single Ascending-Dose, Clinical Study Evaluating the Safety, Tolerability and Exploratory Efficacy of a Targeted Single Injection of an Intradiscal Nuclear Factor-κB Decoy Oligodeoxynucleotide (AMG0103) in Subjects With Chronic Discogenic Lumbar Back Pain


Phase 1b

DESCRIPTION:

Doctors at several coordinating centers in IL, FL, and CA seek patients with chronic lower back pain due to disc degeneration to test a treatment that reduces inflammation through a therapy that can reduce genetic expression of inflammation.

Study participants will receive a low, medium, or high dose of this investigatory treatment via an intradiscal (between the discs) injection, with half of the participants receiving a placebo injection. Over the next several months, the patient will be assessed for pain reduction and X-rayed for disc space improvement, along with some lab assessments and MRIs.


PATIENT MUST:

  • Have chronic lower back pain for at least 6 months that responded poorly to at least 3 months of medical care
  • Be between the ages of 18 to 75 years
  • Not be pregnant
  • Using birth control from the time of enrollment on this study and for one year after treatment.
  • No history of an endocrine or metabolic disorder that affects the spine (eg, Paget’s disease).

THE STUDY INVOLVES:

  1. Screening before the treatment, including lab tests and possibly MRI or X-ray.
  2. An intradiscal injection.
  3. Medical visits at 1 month and 6 months that will include pain assessment, ability assessment, X-ray, MRI, and lab and urine tests.

LOCATIONS AND CONTACTS:

The medical centers conducting this study are

Keck Medicine of USC (Los Angeles, CA)

Contact: Lena Galian    323-442-5303    [email protected]

University of California (San Diego, CA)

Contact: Jesal Parekh    858-822-1288    [email protected]

Spine Institute of San Diego (San Diego, CA)

Contact: Erin Mears    770-365-2555    [email protected]

Florida Medical Pain Management (Saint Petersburg, FL)

Contact: Yulissa Peguero    727-548-6100 ext 280    [email protected]

Rush University Medical Center (Chicago, IL)

Contact: Susan Dvojack    312-942-6689    [email protected]


SPONSOR INFORMATION:

AnGes, Inc. International Clinical Development
81-3-5730-2488
[email protected]

Or go online:
https://go.usa.gov/xnrrA

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