Clinical Trials (Current Research)
Welcome, and thank you for your interest in our clinical research trials!
Please call us at 303-536-1954 or 303-327-5511 to learn more and see if you are a candidate for treatment through one of our studies.
Research administrator: Sara Light
Lead Research Coordinator: Sara Light
Research referrals and questions: 303-536-1954
J. Scott Bainbridge, M.D. (Principal Investigator)
PMR, Pain Medicine
PDF: Study Summary for MESOBLAST LUMBAR DISC STEM CELL STUDY:
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PDF: Scientific Background for MESOBLAST LUMBAR DISC STEM CELL STUDY:
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What is the CASCADE Study?
- The CASCADE Study is a medical research study looking at the effectiveness and safety of a potential new treatment (an investigational product) for degenerative disc disease – a painful condition of the spine. The study will involve approximately 360 patients who are at least 18 years of age.
- Everyone taking part in the CASCADE Study will receive an injection into the painful disc of either the investigational product (which is called rexlemestrocel-L), the investigational product plus hyaluronic acid, or a saline solution, which looks like the investigational medication but contains no active ingredients. You will be randomly assigned (like flipping a coin) to one of these three groups, and neither you nor the study staff performing the follow-up assessments will know who is in which group.
- Visits to the study center for assessments will be required before the injection, on the day of the injection, and 1, 3, 6, 12, 18, 24 and 36 months after the injection. At the end of this study you will be asked to participate in a long-term extension study involving two additional visits at 2 years and 3 years after the injection.
What is rexlemestrocel-L?
- rexlemestrocel-L is a type of adult stem cell therapy that is being evaluated as a possible treatment for degenerative disc disease. Stem cells are unspecialized cells that can turn into various specialized cell types. The stem cells used in making rexlemestrocel-L are called mesenchymal precursor cells (MPC).
- The MPCs in rexlemestrocel-L have been carefully collected from bone marrow samples from healthy human adult donors and grown in a laboratory under very strict conditions. A phase III randomized study is required to evaluate if the stem cells when injected into the painful disc in people with degenerative disc disease may improve pain and other symptoms.
Article on the science of stem cells and their use in the treatment of low back pain related to degenerated lumbar discs:
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Lumbar Disc Herniation Treatment Clinical Trial – Closed to New Enrollment!
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Herniated Disc Study Brochure
Denver Back Pain Specialists is NO LONGER recruiting patients for a research study to treat low back slipped discs causing leg pain. The study is now fully enrolled.
Frequently asked questions (FAQs)
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Denver Back Pain Specialists have also developed protocols to study the treatment of low back pain due to facet and sacroiliac joint pain, low back and leg pain due to disc herniation, and the conservative treatment of cervical radicular (nerve root / arm) pain.