New Phase III stem cell study for treatment of back pain associated with degenerative disc disease

Denver Back Pain Specialists (CO, USA) announces commencement of nationwide FDA-cleared Phase III study of mesenchymal precursor cells for chronic low back pain associated with degenerative disc disease

Go to the profile of Elena Conroy
Jul 28, 2015
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Denver Back Pain Specialists (CO, USA) announced that it has enrolled its first patient in a nationwide FDA-cleared Phase III adult stem cell study to test a treatment for chronic low back pain associated with degenerative disc disease. The study will test the use of mesenchymal precursor cells (MPCs) – adult stem cells derived from bone marrow that will be directly injected into the lumbar disc.

An estimated 30 million people in the USA suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of proteoglycan, a material known to cushion the bones of the spine and enabling normal motion.

Existing therapies consist of medications, physiotherapy and in advanced cases, patients resort to artificial disc replacement or spinal fusion (removal of the degenerated discs and the fusion of the bones of the spine). However, these surgeries are not always entirely effective. This minimally invasive stem cell procedure, if successful, may offer improvement to patients with chronic pain from degenerative disc disease.

Where are we now? Read the latest news in cell therapy for degenerative disc disease:

J Scott Bainbridge, the study leader, sees the critical need for a minimally invasive solution to a common, debilitating condition. "The clinical program is the first of its kind in the United States and we are very excited by the potential of these adult stem cells to provide a novel therapeutic approach," explained Scott Bainbridge.

The current Phase III study will enroll approximately 330 study participants. Up to 20 participants will be enrolled at the Denver site and the rest at multiple other medical centers throughout the USA. All patients will be followed up for 12 months post-treatment.

Denver Back Pain Specialists is enrolling study participants suffering from moderate to severe low-back pain for a minimum of 6 months and whose condition has not responded to current conventional treatments.

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

  • One third will receive a 6 million cell dose of MPCs, plus hyaluronic acid, a substance that facilitates the localization and retention of the stem cells;
  • One third will receive a 6 million cell dose of MPCs alone;
  • One third will receive only the saline solution.

In an outpatient procedure, patients will receive a single injection of the assigned test agent, MPCs, directly into the center of the target spinal disc and will be monitored for safety and efficacy. 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 discs, function and reduction of chronic back pain will also be assessed in each patient.

Additional information on the clinical trial can be found via the www.clinicaltrials.gov study identifier number NCT02412735.

Source: Denver Back Pain Specialists press release: http://www.denverbackpainspecialists.com/denver-back-pain-specialists-physicians-begin-enrollment-in-stem-cell-therapy-study-in-subjects-with-chronic-back-pain/

Go to the profile of Elena Conroy

Elena Conroy

Contributor, Future Science Group

If you have any interest in submitting to the journal Regenerative Medicine or have any queries, please don't hesitate to contact my colleague Adam, Commissioning Editor of the journal https://www.regmednet.com/users/19471-adam-price-evans.

4 Comments

Go to the profile of Lynne Sciandro
Lynne Sciandro over 1 year ago

Has there been any new information available for this treatment? My son, age 24 has severe pain from 2 degenerative discs. His doctor suggested he undergo the stem cell treatment. I like the idea and from what I have read it sounds very promising. My question is how do you know if the doctor who is going to perform the treatment qualified?
Any help or guidance would be appreciated.
Thank you
Lynne

Go to the profile of Freya Leask
Freya Leask over 1 year ago

Hi Lynne - for more information on this clinical trial, you can contact the study coordinators as well as the individual clinics listed on the clinical trial page here: https://clinicaltrials.gov/ct2/show/NCT02412735. They will be able to give you more information about their qualifications too. I hope this is helpful, and best of luck with any treatment!
Freya

Go to the profile of Tim Sexton
Tim Sexton 3 months ago

are they still looking for candidates on this?  If so who should I contact?

Go to the profile of RegMedNet
RegMedNet 3 months ago

Hi Tim - to find out if this clinical trial is still recruiting, you can contact the study coordinators through the clinical trial page: https://clinicaltrials.gov/ct2/show/NCT02412735.