Regenexx Rotator Cuff Stem Cell Procedure Study

Shoulder Rotator Cuff Study Patient Requirements

  • The patient must be willing to come to the Broomfield clinic for first an initial evaluation to make a final determination of study eligibility (includes diagnostic ultrasound)
  • There is no guarantee they will be eligible
  • The cost of this evaluation will be billed to the patient and/or their insurance
  • If eligible, the patient must be willing to return for treatment at the Broomfield clinic and for all post-injection treatments (6 weeks, 3 months, 6 months, 12 months, 24 months)
  • Costs of any travel will be the responsibility of the patient
  • The patient will be randomized to receive either Regenexx-SD treatment or be instructed in a home exercise therapy program
  • Patients in the exercise therapy group will have the opportunity to receive a Regenexx SD treatment after the three month visit if they do not respond to the exercise therapy
  • The Regenexx SD treatment will be provided at no cost to the patient
  • The patient must have a shoulder MRI current within the last year at their own cost for study screening purposes.
  • The subject must meet all inclusion criteria and not meet any exclusion criteria (complete list below). Key criteria include:
    • Age 18-65
    • Can comply with all post-operative evaluations and visits
    • No previous surgery to the affected shoulder
    • No current or past malignancy (cancer)

Inclusion Criteria

Candidates must meet ALL of the following:

  • Voluntary signature of the IRB approved Informed Consent,
  • Skeletally mature Male or Female ages 18 to 65
  • Unremitting pain in the affected shoulder having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy or a corticosteroid injection) for at least 3 months
  • Significant functional disability related to pain, lack of strength, or other shoulder symptoms
  • Physical examination consistent with Rotator Cuff tea
  • Positive diagnostic imaging, which may include arthrogram, ultrasound and/or MR, on the affected shoulder indicating a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes
  • Reasonable movement of the non-treated arm, defined as a shoulder elevation of equal or more than 90°, and able to perform (post-injection) exercises
  • Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria

Candidates will be excluded if they meet ANY of the following:

  • A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
  • Previous surgery to the affected shoulder
  • Prior rotator cuff prolotherapy, PRP or other RC injection-based therapies within the past three months,
  • Concomitant tears of multiple rotator cuff or biceps tendons
  • Grade 2 or greater SLAP tear
  • Type 3 acromion
  • Significant bone spur in subacromial space
  • Inflammatory or auto-immune based joint diseases or other upper extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
  • Quinolone or Statin induced myopathy/ tendinopathy
  • Kellgren-Lawrence grade 2 or greater glenohumeral osteoarthritis
  • Adhesive capsulitis (mild or severe)
  • Symptomatic cervical spine pathology (e.g. radicular cervical pain)
  • Severe neurogenic inflammation of the cutaneous nerves about the shoulder
  • Shoulder instability requiring surgical stabilization
  • Contraindications for MRI
  • Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
  • Condition represents a worker’s compensation case
  • Currently involved in a health-related litigation procedure
  • Is pregnant
  • Bleeding disorders
  • Currently taking anticoagulant or immunosuppressive medication
  • Allergy or intolerance to study medication
  • Use of chronic opioid,
  • Documented history of drug abuse within six months of treatment
  • Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

If you meet all of the criteria for a study and are able to travel to the research study location for all of the required follow-up of visits, please contact us at 404.800.0302. or via email at [email protected]

Regenerative procedures are commonly used to treat musculoskelatal trauma, overuse injuries, and degenerative issues, including failed surgeries.
Select Your Problem Area
Shoulder

Shoulder

Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. Before considering shoulder arthroscopy or shoulder replacement, consider an evaluation of your condition with a regenerative treatment specialist.

  • Rotator Cuff Tears and Tendinitis
  • Shoulder Instability
  • SLAP Tear / Labral Tears
  • Shoulder Arthritis
  • Other Degenerative Conditions & Overuse Injuries
Learn More
Cervical Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Knee

Knees

Knees are the target of many common sports injuries. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. Regenerative procedures can be used to treat a wide range of knee injuries and conditions. They can even be used to reduce pain and delay knee replacement for more severe arthritis.

  • Knee Meniscus Tears
  • Knee ACL Tears
  • Knee Instability
  • Knee Osteoarthritis
  • Other Knee Ligaments / Tendons & Overuse Injuries
  • And more
Learn More
Lower Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Hand & Wrist

Hand & Wrist

Hand and wrist injuries and arthritis, carpal tunnel syndrome, and conditions relating to overuse of the thumb, are good candidates for regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Hand and Wrist Arthritis
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb)
  • Other conditions that cause pain
Learn More
Elbow

Elbow

Most injuries of the elbow’s tendons and ligaments, as well as arthritis, can be treated non-surgically with regenerative procedures.

  • Golfer’s elbow & Tennis elbow
  • Arthritis
  • Ulnar collateral ligament wear (common in baseball pitchers)
  • And more
Learn More
Hip

Hip

Hip injuries and degenerative conditions become more common with age. Do to the nature of the joint, it’s not quite as easy to injure as a knee, but it can take a beating and pain often develops over time. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures.

  • Labral Tear
  • Hip Arthritis
  • Hip Bursitis
  • Hip Sprain, Tendonitis or Inflammation
  • Hip Instability
Learn More
Foot & Ankle

Foot & Ankle

Foot and ankle injuries are common in athletes. These injuries can often benefit from non-surgical regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Ankle Arthritis
  • Plantar fasciitis
  • Ligament sprains or tears
  • Other conditions that cause pain
Learn More

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*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.