This is an Open Label Phase I/II Pilot Study to Evaluate the safety and tolerability of NuQu and the injection procedure employed to deliver NuQu to the nucleus pulposus of degenerated intervertebral discs.  The study will also  assess the activity of NuQu through evaluation of preliminary effectiveness in relieving back pain.

NuQu™ is a cryopreserved suspension of culture-expanded, allogeneic human juvenile chondrocytes intended for injection into the lumbar disc nucleus using commercially prepared fibrin carrier.

Inclusion Criteria (abbreviated list) –

1. Have provided consent by signing the Institutional Review Board approved Informed

    Consent;

2. Are male or female between the age of 18 to 70 years of age;

3. If female, must have a negative pregnancy test at the time of treatment, be actively

    practicing contraception or abstinence, be surgically sterilized or be postmenopausal;

4. Have central low back pain aggravated by movement and or postural changes      (standing/sitting);

5. Have tried and failed at least 12 weeks of conservative management as directed by a

    licensed physician, chiropractor and or physical therapist.  Treatment must include any 

    or a combination of physical therapy, chiropractic care or pain management.  This may

    include but is not limited to rest or activating physical therapy, heat,  cold, electrical

    stimulation, ultrasound, manipulation, acupuncture, analgesics including narcotics (with

    no history of abuse) anti-inflammatory medication and radiofrequency and spinal

      injections;

7. Have been and refused the alternate treatment alternatives of steroid use, spinal

    injection, nerve ablation and surgical intervention; 

For more information contact Crystal Hill at (919) 281-1870 or chill@triangleortho.com