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Denver Spine Physicians Begin Enrollment in United States Stem Cell Therapy Study
Date:12/13/2011

ate low-back pain for a minimum of six months and whose condition has not responded to other, conventional treatments.

Once enrolled, patients are randomly assigned to one of four treatment groups:

  • One group will receive a high dose of MPCs, plus hyaluronic acid, a substance that facilitates the localization and retention of the stem cells;
  • A second group will receive a lower dose of MPCs, plus the hyaluronic acid;
  • A third group will receive the hyaluronic acid alone;
  • A fourth group will receive only the saline solution.

Patients will receive a single injection of their assigned test agent directly into the center of the target discs within their spine and will be monitored for safety.  Patients will also be monitored using imaging to identify any changes in their disease condition or disease progression. Use of pain medications, self-reports of pain, subsequent surgical interventions and assessments of disability, quality of life, productivity and activity will be evaluated. Repair of the disc and reduction of chronic back pain will be assessed in each patient. 

Promising results have been observed in prior research using animal models when stem cells were investigated for the repair of damaged spine discs.The cells were well tolerated in these study animals.

This study is sponsored by Mesoblast Limited,a world leader in the development of biologic products for the broad field of regenerative medicine.  Mesoblast has the worldwide exclusive rights to a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs).  The MPCs are derived from young adult donors' bone marrow and are immune tolerant.

For more information, go to www.denverspine.com.

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