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Regenerative Cell Therapy
For Rotator Cuff Tears

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Eligibility Requirements

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Females and males
ages 30 – 75

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Experiencing shoulder
pain, or lack of shoulder strength

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MRI diagnosis of a
partial rotator cuff tear

(Patients who do not have
an MRI may still apply)

About the Trial

  • The clinical study uses regenerative cells in patients who have partial thickness rotator cuff tears. These are tears in the tendon that contribute to shoulder pain, dysfunction, and occupational disability.
  • In this study, regenerative cells from your fat tissue will be isolated, concentrated, and injected into your tendon tear. You will receive either a steroid injection or an in injection of your own regenerated cells. *

* The use of regenerative cells is investigational. We are studying the safety and effectiveness of this treatment compared to steroid injections.

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About Rotator Cuff Tears

  • Rotator cuff tears are the leading cause of shoulder
    pain in the US.
  • These tears are very common, affecting 4 million
    Americans every year. As many as half of Americans over the age of 60 have a partial rotator cuff tear.
  • Treating these tears can be difficult. Unfortunately, many partial tears go on to become full tendon tears that require surgery.

Post Treatment Expectations

Following the procedure day, you’ll have 4 follow-up visits with the physician who performed the procedure:

These visits will include a physical exam, questions about your health history and medications, surveys, lab testing and radiographic exams.

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2 weeks

1st Follow up visit:

  • Physical Exam
  • Shoulder Evaluation
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6 weeks

2nd Follow up visit:

  • Physical Exam
  • Shoulder Evaluation
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12 weeks

3rd Follow up visit:

  • Physical Exam
  • Shoulder Evaluation
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24 weeks

4th Follow up visit:

  • Physical Exam
  • Shoulder Evaluation
  • MRI of the shoulder
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Who is conducting this
clinical trial?

  • InGeneron is a biotechnology company creating
    innovative, cell-based technologies for the next
    generation of medicine.
  • For the past 20 years, we have focused on helping
    patients impacted by orthopedic conditions.
  • We are dedicated to developing therapies supported
    by quality clinical evidence and approved by the FDA.

About Rotator Cuff Tears

Arizona

Dr. Taber

Arizona Research Center 15601 N. 28th Avenue, Suite 100

Phoenix, AZ 85053

Email: rgledhill@azresearchcenter.com

Tel: +1 (602) 863 6363

Florida

Dr. Manish Gupta

Sports and Orthopedic Center 6280 W. Sample Road Suite 202

Coral Springs, FL 33067

Email: viveks@pioneerclinical.com

Tel: +1 (954) 857 8002

Dr. Joshua Hackel

Andrews Research & Education Foundation 1020 Gulf Breeze Parkway

Gulf Breeze, FL 32561

Email: kelly.derbes@andrewsref.org

Tel: +1 (850) 916 8584

Dr. Luis Martinez

Universal Axon Clinical Research, LLC 3650 NW 82nd Ave

Doral, FL 33166 Angel Benitez

Email: abenitez@uaclinical.com

Tel: +1 (305) 677 9267 x 19

Georgia

Dr. Anthony Grasso

Georgia Institute for Clinical Research 335 Roselane St NW Floor 2, Room 203

Marietta, GA 30060

Email: lee.robinson@lowbackpain.com

Tel: +1 (770) 421 2037

Louisiana

Dr. Jaime Garza

Tulane University School Of Medicine 1440 Canal Street Suite 1700 Unit 8471

New Orleans, LA 70112

Email: oidowu@tulane.edu

Tel: +1 (504) 988 6834

North Dakota

Dr. Mark Lundeen

Sanford Health System – Sanford Orthopedics and Sports Medicine – Fargo 2301 25th Street South

Fargo, ND 58103

Email: stemcelltherapy@sanfordhealth.org

Tel: +1 (605) 312 6020

South Dakota

Dr. Harvey Oliver

Sanford Health System – Sanford Orthopedics and Sports Medicine – Sioux Falls 1210 W 18th Street Suite G01 Route 6771

Sioux Falls, SD 57104

Email: stemcelltherapy@sanfordhealth.org

Tel: +1 (605) 312 6020

Texas

Dr. Solanki

HD Research 4801 Bissonett St

Bellaire, TX

Email: sveramustafa@minkowitzmd.com

Tel: +1 (713) 367 8548

Dr. Jaime Garza

Texas Plastic Surgery 21 Spurs Lane, Suite #120

San Antonio, Texas 78240

Email: jkrieger@txps.net

Tel: +1 (210)-355-5046

California

Dr. Alina Beaton

Lotus Clinical Research, LLC 100 W. California, Unit 25

Pasadena, CA 91105

Email: jnelson@lotuscr.com

Tel: +1 (626) 397 3485

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Contact your nearest clinical site to learn more.

Frequently Asked Questions

What are stem cells?

Stem cells serve as the starting material of the body and the precursor to all other cell types. Stem cells are unspecialized cells capable of transforming into a range of other cell types but also able to replicate themselves to produce more stem cells. The body uses stem cells to heal and regenerate tissues by activating the stem cells to mature into the type of cell needed by the body.

What are adipose-derived regenerative cells (ADRCs)?
  • Regenerative cells are cell types that naturally promote tissue regeneration and homeostasis by facilitating the generation of new cells to replace old or injured cells in a particular tissue. Adipose-derived regenerative cells, also known as Stromal Vascular Fraction, are cells isolated from adipose (fat) tissue, where they are found in high concentrations. Regenerative cells include stem cells, notably vaPS cells, and MSCs, which can mature into multiple cell types, progenitor cells, macrophages, and other cell types that promote tissue regeneration and healing. These cells work together through a complex system of signaling, resulting in synergistic healing effects that are greater than the effect that any one cell type can have on its own.
  • Multiple studies show that ADRCs can be effective in treating a variety of soft tissue and bone conditions and have a high safety profile.
How do I find out if I qualify for the study?

If you are interested in joining this study please use the contact button at the top of the page to send us a message or reach out to your nearest clinical site using the map above.