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Drs. Bainbridge and Trainor Attend Regenerative Medicine Conference in California

March 15th, 2017

Dr. Bainbridge and Dr. Trainor recently attended a regenerative medicine conference in Newport Beach California to learn more about the regenerative and healing properties of mesenchymal stem cells (MSCs) and platelet rich plasma (PRP).  Specifically, they learned the value of using both stem cells and platelet rich plasma in combination to take advantage of the unique characteristics of both to provide the best possible outcomes for their patients in the treatment of back, joint, and tendon problems.  They also learned new, relatively pain free ways to collect stem cells from both the bone marrow and adipose tissue (fat) to make the process as comfortable as possible for their patients.  If you have questions about regenerative medicine and whether or not this might be a good treatment option for you, please call 303-327-5511 and schedule a consultation today.

Drs. Trainor and Bainbridge participate in Workers’ Compensation Treatment Guidelines Task Force

March 2nd, 2017

Dr. Trainor and Dr. Bainbridge have appreciated the recent opportunity to participate as members of the Workers’ Compensation Chronic Pain Disorder & Complex Regional Pain Syndrome Medical Treatment Guidelines Task Force.

Dr. Bainbridge DOWC Dr. Trainor DOWC

Wounded Warriors Program

June 17th, 2016

Proud Member of the Interventional Orthopedics Foundation’s Wounded Warriors Program. Learn More

Article: “Regenerative Orthopedics Offer New Hope to Injured Soldiers”

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Dr. Bainbridge interviewed on No Copay Radio

June 17th, 2016

Dr. Bainbridge enjoyed meeting and talking with Dr. John Torres and Murphy Houston on March 12th, 2016 on No Copay Radio (www.nocopayradio.com).
Listen to the conversation about low back pain, beginning at 15:50 minutes, at:

http://nocopayradio.com/2016/04/13/live-on-the-radio-march-12th/

Stem Cell Study for Back Pain Begins

August 1st, 2015

Dr. Bainbridge is quoted in this article about the CASCADE study, at Pain News Network. Click on title above, then click HERE for full article.

Denver Back Pain Specialists Physicians Begin Enrollment in Stem Cell Therapy Study in Subjects with Chronic Back Pain

July 23rd, 2015

Denver Back Pain Specialists today announced that it has enrolled its first patient in a nationwide FDA- cleared adult stem cell study (phase 3) testing an investigational 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 United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion.

Most patients with low back pain respond to physical therapy and medications, but in advanced cases, artificial disc replacement or spinal fusion – removal of the degenerated discs and the fusion of the bones of the spine – may be performed. However, these surgeries often are not entirely effective.This minimally invasive stem cell procedure, if successful, may offer improvement to patients with chronic pain from degenerative disc disease.

J. Scott Bainbridge M.D. is Denver Back Pain Specialists’ principal investigator for this study and is leading a team of researchers. He 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,” Dr. Bainbridge said.

The current Phase 3 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 United States. Patients will be followed 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 six months and whose condition has not responded to conventional treatments.

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

  • One third (1/3) 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 (1/3) will receive a 6 million cell dose of MPCs alone;
  • One third (1/3) 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 be assessed in each patient.

Dr Bainbridge took part in the preceding phase 2 clinical trial, which found that the cells were well tolerated. The 6 million cell dose resulted in a greater proportion of patients achieving reduced back pain compared to patients who did not receive the cells.

This study is sponsored by Mesoblast Limited, a world leader in cell-based 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 MPCs.

For more information, go to www.denverbackpainspecialists.com or call 303-522-5219.

For additional information on the clinical trial, please see the listing on www.clinicaltrials.gov study identifier number NCT02412735.

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POSITIVE SPINAL DISC REPAIR TRIAL RESULTS USING MESOBLAST ADULT STEM CELLS

February 23rd, 2014

NEW YORK and MELBOURNE, Australia, Jan. 29, 2014 (GLOBE NEWSWIRE) — Regenerative medicine company Mesoblast Limited (ASX:MSB; USOTC:MBLTY) today announced positive 12 month outcome results from the 100-patient Phase 2 clinical trial of its proprietary allogeneic, or “off-the-shelf”, Mesenchymal Precursor Cells (MPCs) in patients with chronic moderate to severe discogenic low back pain.

The results showed that a single injection of MPCs into degenerating intervertebral discs reduced low back pain and improved function for at least 12 months. When compared with controls, MPC-treated patients used less opioids for pain relief, had greater radiographically-determined disc stability, and underwent less additional surgical and non-surgical treatment interventions. MPC treatments also appeared to be well tolerated during the study.

Mesoblast Chief Executive Silviu Itescu said: “We are very pleased that in a trial primarily designed to assess the safety of Mesoblast’s cells for intervertebral disc repair, we have seen strong indications of sustained efficacy across a broad number of clinical and radiographic parameters after a single intra-disc injection. On the basis of these positive results, Mesoblast plans to meet shortly with regulatory authorities in major jurisdictions, including the United States Food and Drug Administration, to discuss product registration trials for the potential treatment of disc degeneration.”

Dr Hyun Bae, Clinical investigator and Medical Director, Director of Education, Cedars-Sinai Spine Center, Cedars-Sinai Medical Center, Los Angeles, and Medical Director of Spine Institute, Santa Monica, USA, said: “We are very excited by these results. This is compelling evidence that Mesoblast’s stem cell technology has the potential to change the treatment of spinal disease from focusing on surgical reconstruction to biologic regeneration. Physicians and patients are seeking access to a new modality to treat patients with this highly debilitating disease for whom there are limited options. We hope that these outcomes will be replicated in a pivotal trial.”

The results of the Phase 2 clinical trial build on and extend previously reported preclinical studies which showed that Mesoblast’s highly purified and immunoselected MPCs were able to increase proteoglycan content and improve disc structure in an experimental ovine model of disc degeneration.

Mesoblast’s Phase 2 clinical trial enrolled 100 patients with moderate to severe low back pain persisting for more than 6 months and caused by early disc degeneration (less than 30% disc height loss, 83% below Pfirrmann Grade 5 by MRI). Patients were enrolled across 13 sites in the United States and Australia and randomized to receive direct intra-disc injection of saline (n equals 20), hyaluronic acid (HA, n equals 20), 6 million allogeneic MPCs in hyaluronic acid carrier (6M, n equals 30) or 18 million allogeneic MPCs in hyaluronic acid carrier (18M, n equals 30). Patients underwent the outpatient injection for a single painful degenerated lumbar level and are being evaluated for safety and efficacy over a total of 36 months to evaluate long-term treatment effects.

Key findings at 12 months were:

— Improvement in chronic low back pain

(a) Reduction in mean pain score: While mean pain scores, as measured by a Visual Analog Scale (VAS), were similar for all four groups at baseline (67 points for saline, 72 points for HA, 70 points for 6M MPC, 72 points for 18M MPC), at 12 months MPC treatment resulted in significantly greater pain reduction than was seen in controls. Mean pain reduction at 12 months was 40 points for the 18M MPC group, 37 points for the 6M MPC group, 27 points for HA controls, and 27 points for saline controls (p equals 0.046 and p equals 0.11, respectively, for 18M MPC and 6M MPC vs pooled controls).

(b) Increased proportion of patients achieving greater than 50% reduction in pain score: Achieving more than 50% reduction in low back pain at 12 months is considered by many patients and physicians as a key target. A significantly greater proportion of MPC treated patients achieved at least a 50% reduction in low back pain at 12 months, as measured by VAS, than controls (6M MPC 69%, 18M MPC 62%, HA 35%, saline 31%, p equals 0.036 between groups). Both MPC dose groups had a significantly greater proportion of patients with 50% or more reduction in back pain from baseline compared to the pooled controls (6M, p equals 0.009, 18M p equals 0.038).

(c) Increased proportion of patients achieving minimal residual back pain: Minimal residual back pain at 12 months was considered if the VAS score was less than or equal 20. A significantly greater proportion of MPC treated patients achieved minimal residual back pain at 12 months than controls (6M group 52%, 18M group 42%, pooled controls 18%, p equals 0.01 and p equals 0.05, respectively).

(d) Reduced opioid use for pain relief: At 12 months, mean daily use of opioid medications for back pain was reduced by as much as 42% in the 18M MPC group compared with the saline control group (p equals 0.17). Mean opioid use was 1.00 tablet/day saline group, 0.94 tablet/day HA group, 0.77 tablet/day 6M MPC group, and 0.58 tablet/day 18 MPC group. Mean opioid use was also over two-fold higher in saline and HA controls achieving greater than or equal to 50% reduction in pain score than in MPC treated patients, indicating that pain reduction in the controls may have been due to high opioid intake rather than to any biologic effect (mean opioid use 1.3 and 1.2 tablets/day in saline and HA controls compared with 0.7 and 0.6 tablets/day for the 6M and 18M MPC groups).

(e) Reduced need for additional surgical and non-surgical interventions for persistent pain: MPC-treated patients had a significantly reduced need for additional interventions at the treated disc level, including surgical intervention (spine fusion, discectomy or artificial disc replacement) or injection (epidural steroid injection, rhizotomy or transforaminal injections), than saline controls. By 12 months, 25% saline controls had undergone an additional intervention, compared with 10% HA controls, 6.9% of 6M MPC and only 3.3% of 18M MPC treated patients. By Kaplan-Meier analysis of time to a first additional treatment intervention, treatment with either 6M or 18M MPC significantly reduced the need for additional interventions compared with saline treatment (p equals 0.024 and p equals 0.010, respectively).

— Improvement in function

(a) Reduction in mean disability score: At 12 months, MPC treatment resulted in greater improvement in function than was seen in controls, as measured by the Oswestry Disability Index (ODI). Mean reduction in the ODI functional disability score was 43% for the 18M MPC group, 35% for the 6M MPC group, 30% for HA controls, and 28% for saline controls (p equals 0.09 for 18M MPC group vs saline).

(b) Increased proportion of patients achieving minimal residual functional disability: Minimal residual functional disability at 12 months was considered if the ODI score was less than or equal to 20. A greater proportion of MPC treated patients achieved minimal residual functional disability at 12 months than controls (18M group 39%, 6M group 36%, pooled controls 18%, p equals 0.14 and p equals 0.14, respectively).

— Improvement in disc stability

In patients with early disc degeneration (Pfirrmann MRI degenerative grades below 5), increased translational movement of the disc is a potential indicator of instability associated with early disc degeneration and annular fissures seen on MRI and pathologic examination. At 12 months, MPC-treated patients demonstrated a significant reduction in radiographically-determined translational movement of the disc, suggesting a treatment effect on disc degeneration, anatomy, and improved disc stability. The 18M MPC group had a mean translational movement of only 1.3%, the 6M MPC group 2%, the HA group 2.5%, and the saline group 3.5% (p equals 0.021 between groups). When adjusting translation per degree of rotation (TPDR), a similar treatment effect on reduced translational movement was seen in both the 6M and 18M MPC groups.

— Safety:

Allogeneic MPC treatment was well tolerated with the most frequently reported adverse event, back pain, occurring across all treatment groups.

About Chronic Degenerative Intervertebral Disc Disease

More than 6 million patients in the United States alone are currently dealing with chronic back pain that has persisted for at least three months, with around 3.5 million people affected by moderate or severe degenerative intervertebral disc disease. The United States Centers for Disease Control and Prevention’s National Center for Health Statistics reported in 2010 that low back pain was the leading cause of pain, affecting 28% of American adults, and the second most common cause of disability in American adults. The United States lifetime prevalence of low back pain is estimated to be at least 60 to 84%. Total costs of low back pain are estimated to be between $100 billion and $200 billion annually, two thirds of which are due to decreased wages and productivity. Treatment for chronic back pain of discogenic origin includes conservative treatment, analgesia, anti-inflammatory agents, epidural steroid injections, and ultimately surgical intervention. Discogenic back pain is the end result of a complex process initiated by degeneration and loss of proteoglycan and water content of the nucleus pulpous, and increased stress on and fissure formation of the annulus fibrosis.

About Mesoblast

Mesoblast Limited (ASX:MSB; USOTC:MBLTY) is a world leader in the development of biologic products for the broad field of regenerative medicine. The Company’s proprietary technologies include its highly purified, immunoselected Stro-1/Stro-3 positive Mesenchymal Precursor Cells (MPCs), culture-expanded Mesenchymal Stem Cells (MSCs), Dental Pulp Stem Cells (DPSCs), and expanded Hematopoietic Stem Cells (HSCs). Mesoblast’s protein technologies are based on factors derived from its proprietary cellular platforms, including Stromal Derived Factor-1 (SDF-1). Mesoblast’s allogeneic or ‘off-the-shelf’ regenerative medicine products are being developed for the treatment of conditions with significant unmet medical needs. Product development focus is in four major and distinct areas – systemic diseases with an underlying inflammatory and immunologic etiology; cardiac and vascular diseases; orthopedic diseases of the spine; and improving outcomes of bone marrow transplantation associated with oncology or genetic conditions. www.mesoblast.com

ISIS Helps Improve New CO Workers’ Compensation Back and Neck Pain Treatment Guidelines

February 16th, 2014

The new Colorado Workers’ Compensation Low Back Pain and Cervical Injury Treatment Guidelines were posted earlier this week. These are a culmination of almost a year’s worth of work and revision by the leaders of the Colorado Division of Labor, the Treatment Guidelines Task Force, The Treatment Guidelines Advisory Panel, a group of Colorado physicians, and the very welcome help of the International Spine Intervention Society (ISIS).

The originally released draft of these Treatment Guidelines was very restrictive with respect to patient access to spine intervention (injection) care. They were based on a very narrow interpretation of the available evidence, using a somewhat biased “Evidence-based Medicine” approach, with an overemphasis on cost savings. See the Evidence-based Medicine discussion on this website. The advisory panel and a group of Colorado physicians enlisted the help of ISIS to help support revisions to these original drafts. ISIS worked tirelessly, under very short time restraints, to produce a written statement of recommended improvements to the guidelines, and the leaders of the CO Department of Labor and Employment, Division of Workers’ Compensation, showed great wisdom in adopting many of those proposals. Denver Back Pain Specialists would like to thank all of those involved in the creation of these guidelines, especially ISIS.

Disclosure (J. Scott Bainbridge, M.D.): Dr. Bainbridge served on the Treatment Guidelines Advisory Panel, presented the ISIS recommendations at the November 19, 2013 public hearings, and is a former member of the ISIS Board of Directors.

Physiatrists and Pre-Surgical Spine Consultation

February 4th, 2013

A recently published article in the journal “Spine”[1] highlights the important role that physiatrists (Physical Medicine and Rehabilitation specialists) have in managing spine patients who may be surgical candidates.  The study looks at the effect of an insurance carriers’ decision to require consultation with a physiatrist before spine surgery.  The result was a reduction in spine surgery rates, while maintaining patient satisfaction.  The authors discuss the inherent biases of primary care physicians, spine surgeons, and physiatrists and the perception of spine patients. It is true that some physiatrists are too conservative and some spine surgeons are too aggressive. However, Dr. Bainbridge combines over twenty years of working closely with spine surgeons with a working knowledge of the indications for spine surgery and the benefits and limitations of conservative care and injection options. He councils and educates patients with respect to all treatment options in a manner that allows for clear decision making and optimal outcomes.

Referrals for consultation can be made by calling Denver Back Pain Specialists at 303-327-5511 or faxing our referral form (Referral to Dr. Bainbridge – Denver Back Pain Specialists) to 303-327-5512. New patient forms can be found on our Forms and Facts page. We appreciate your confidence and strive to deliver the best care possible (Mission and Services of DBPS).

1.                  Fox, J., et al., The effect of required physiatrist consultation on surgery rates for back pain. Spine (Phila Pa 1976), 2013. 38(3): p. E178-84.

Safe Injection Practice Guidelines

October 9th, 2012

The medical care providers at Denver Back Pain Specialists follow Federal Drug Agency (FDA), Centers for Disease Control and Prevention (CDC), and state and federal guidelines and regulations regarding safe injection administration. All substances used for injection come from the manufacturers, which are regulated by the FDA, or from  PCAB accredited compounding pharmacies. Details regarding injection guidelines and drug packaging monitoring can be found in the following downloadable documents:

CDC Guidelines | One and Only Campaign

CDC Single Dose Vial Position 5.2012

Facts About Current Good Manufacturing Practices (cGMPs)

Pharmacies Licensed to Prepare Compounded Drugs | PCAB.org