A Clinical Registry of Orthobiologics Procedures

NCT ID: NCT03011398

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 50000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2036-02-29

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.

Detailed Description

This Registry was designed to assure that the benefits and knowledge gained by studying clinical outcomes associated with the use of percutaneous orthopedic procedures outweigh the potential risks to the patients. The primary objective of this Registry is to observe the improvements in subject-reported clinical outcomes for these procedures used to treat musculoskeletal disorders. Secondary objectives include evaluating post-treatment complication, adverse events, re-injections, and surgical intervention. Patients receiving percutaneous orthopedic treatments are asked to enroll before receiving treatment and complete a set of baseline questionnaires regarding pain and functionality of the area of the body being treated (i.e. knee, shoulder, spine, etc). Follow-up outcomes are collected at 1 month, 3 months, 6 months, 12 months, 18 months, and annually 2-20 years post-injection. Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Conditions

Orthopedic Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Orthobiologic Procedures

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Candidates must meet ALL of the following:

1. Voluntary signature of the IRB approved Informed Consents,

2. Treated with a Regenexx procedure

3. 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

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regenexx, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Centeno, MD

Role: PRINCIPAL_INVESTIGATOR

Regenerative Sciences, LLC and Centeno-Schultz Clinic

Locations

Catalyst Pain Solutions

Phoenix, Arizona, United States

Healthlink Center

Beverly Hills, California, United States

Healthlink Center

Oceanside, California, United States

Healthlink Center

San Rafael, California, United States

Southern California Orthopedic Institute

Thousand Oaks, California, United States

Southern California Orthopedic Institute-Van Nuys

Van Nuys, California, United States

Centeno-Schultz Clinic

Broomfield, Colorado, United States

Regenexx

Broomfield, Colorado, United States

New reGeneration Orthopedics

Sarasota, Florida, United States

Chicago Arthritis

Chicago, Illinois, United States

Orthopedic Stem Cell Resource

Des Plaines, Illinois, United States

Harbor View Medical

Des Moines, Iowa, United States

Bodyworks Musculoskeletal Medicine

Louisville, Kentucky, United States

Total Care-LA

Lafayette, Louisiana, United States

Stem Cell ARTS-MD

Chevy Chase, Maryland, United States

RejuvMedical

Waite Park, Minnesota, United States

New Jersey Sports Medicine

Cedar Knolls, New Jersey, United States

Orthopedic Stem Cell Solutions

Oakhurst, New Jersey, United States

Rehabilitation Center of New Jersey

Wayne, New Jersey, United States

Rehabilitation Center of New York

New York, New York, United States

Beacon Orthopaedics

Cincinnati, Ohio, United States

ProMedica

Toledo, Ohio, United States

RegenOrthoSport

Tulsa, Oklahoma, United States

Columbia Pain Management

Hood River, Oregon, United States

Rehabilitation and Pain Specialists

Pittsburgh, Pennsylvania, United States

Center for Sports Medicine

Springfield, Pennsylvania, United States

RegenOrthoSport

Dallas, Texas, United States

Wasatch Pain Solutions

South Jordan, Utah, United States

Vermont Regenerative Medicine

Winooski, Vermont, United States

Stem Cell ARTS-VA

McLean, Virginia, United States

Nepean Specialist Sports Medicine

Kingswood, New South Wales, Australia

RegenOrthoSport

Hyderabad, Telangana, India

Countries

United States; Australia; India

References

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.

Reference Type: BACKGROUND

PMID: 19951252 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22023622 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16956842 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20392971 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20603892 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35932306 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35844014 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30176875 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28938891 (View on PubMed)

Other Identifiers

RSI2015-REG01

Identifier Type: -

Identifier Source: org_study_id