A Clinical Registry of Orthobiologics Procedures

NCT03011398 | Enrolling By Invitation

• 1 other identifier: RSI2015-REG01
• Study Type: observational
• Target: 50,000
• Locations: 3 countries
• Sites: 32

Brief Summary

The purpose of the Registry study is to observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Percent Improvement

  Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline

  1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

Secondary Outcomes (10)

• Pain Scale

  1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

• International Knee Documentation Committee form

  1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

• Lower Extremity Function Scale

  1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

• Disabilities of the Arm, Shoulder and Hand form

  1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

• Oxford Hip Score

  1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

Interventions

Orthobiologic Procedures PROCEDURE

To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated with orthobiologics procedures

You may qualify if:

• Candidates must meet ALL of the following:
• Voluntary signature of the IRB approved Informed Consents,
• Treated with a Regenexx procedure
• Have a musculoskeletal condition appropriate for the procedure such as osteoarthritis or internal joint derangement; ligament or tendon injury; intervertebral disc degeneration; protrusion, extrusion, or annular tear; muscle tear

You may not qualify if:

• none

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (32)

Catalyst Pain Solutions

Phoenix, Arizona, 85008, United States

Location

Healthlink Center

Beverly Hills, California, 90035, United States

Location

Healthlink Center

Oceanside, California, 92056, United States

Location

Healthlink Center

San Rafael, California, 94903, United States

Location

Southern California Orthopedic Institute

Thousand Oaks, California, 91361, United States

Location

Southern California Orthopedic Institute-Van Nuys

Van Nuys, California, 91405, United States

Location

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Regenexx

Broomfield, Colorado, 80026, United States

Location

New reGeneration Orthopedics

Sarasota, Florida, 34243, United States

Location

Chicago Arthritis

Chicago, Illinois, 60657, United States

Location

Orthopedic Stem Cell Resource

Des Plaines, Illinois, 60016, United States

Location

Harbor View Medical

Des Moines, Iowa, 50321, United States

Location

Bodyworks Musculoskeletal Medicine

Louisville, Kentucky, 40223, United States

Location

Total Care-LA

Lafayette, Louisiana, 70503, United States

Location

Stem Cell ARTS-MD

Chevy Chase, Maryland, 20815, United States

Location

RejuvMedical

Waite Park, Minnesota, 56387, United States

Location

New Jersey Sports Medicine

Cedar Knolls, New Jersey, 07927, United States

Location

Orthopedic Stem Cell Solutions

Oakhurst, New Jersey, 07755, United States

Location

Rehabilitation Center of New Jersey

Wayne, New Jersey, 07470, United States

Location

Rehabilitation Center of New York

New York, New York, 10001, United States

Location

Beacon Orthopaedics

Cincinnati, Ohio, 45241, United States

Location

ProMedica

Toledo, Ohio, 43612, United States

Location

RegenOrthoSport

Tulsa, Oklahoma, 74136, United States

Location

Columbia Pain Management

Hood River, Oregon, 97031, United States

Location

Rehabilitation and Pain Specialists

Pittsburgh, Pennsylvania, 15238, United States

Location

Center for Sports Medicine

Springfield, Pennsylvania, 19064, United States

Location

RegenOrthoSport

Dallas, Texas, 75230, United States

Location

Wasatch Pain Solutions

South Jordan, Utah, 84095, United States

Location

Vermont Regenerative Medicine

Winooski, Vermont, 05404, United States

Location

Stem Cell ARTS-VA

McLean, Virginia, 22102, United States

Location

Nepean Specialist Sports Medicine

Kingswood, New South Wales, 2747, Australia

Location

RegenOrthoSport

Hyderabad, Telangana, 500001, India

Location

Related Publications (9)

• Centeno CJ, Schultz JR, Cheever M, Robinson B, Freeman M, Marasco W. Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2010 Mar;5(1):81-93. doi: 10.2174/157488810790442796.

  PMID: 19951252 BACKGROUND

• Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174/157488811797904371.

  PMID: 22023622 BACKGROUND

• Bain BJ. Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Haematologica. 2006 Sep;91(9):1293-4.

  PMID: 16956842 BACKGROUND

• Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14.

  PMID: 20392971 BACKGROUND

• Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299.

  PMID: 20603892 BACKGROUND

• Centeno CJ, Berger DR, Money BT, Dodson E, Urbanek CW, Steinmetz NJ. Percutaneous autologous bone marrow concentrate for knee osteoarthritis: patient-reported outcomes and progenitor cell content. Int Orthop. 2022 Oct;46(10):2219-2228. doi: 10.1007/s00264-022-05524-9. Epub 2022 Aug 6.

  PMID: 35932306 DERIVED

• Centeno CJ, Money BT, Dodson E, Stemper I, Steinmetz NJ. The rate of venous thromboembolism after knee bone marrow concentrate procedures: should we anticoagulate? Int Orthop. 2022 Oct;46(10):2213-2218. doi: 10.1007/s00264-022-05500-3. Epub 2022 Jul 18.

  PMID: 35844014 DERIVED

• Centeno C, Markle J, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. J Transl Med. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3.

  PMID: 30176875 DERIVED

• Centeno C, Markle J, Dodson E, Stemper I, Williams CJ, Hyzy M, Ichim T, Freeman M. Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy. J Transl Med. 2017 Sep 22;15(1):197. doi: 10.1186/s12967-017-1300-y.

  PMID: 28938891 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Christopher Centeno, MD

  Regenerative Sciences, LLC and Centeno-Schultz Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 5, 2017
• Study Start: February 1, 2016
• Primary Completion (Estimated): February 1, 2036
• Study Completion (Estimated): February 1, 2036
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); AU (1); US (30)