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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03011398




Registration number
NCT03011398
Ethics application status
Date submitted
29/12/2016
Date registered
5/01/2017
Date last updated
28/09/2023

Titles & IDs
Public title
A Clinical Registry of Orthobiologics Procedures
Scientific title
Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures
Secondary ID [1] 0 0
RSI2015-REG01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthopedic Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Orthobiologic Procedures

Treatment: Surgery: Orthobiologic Procedures
To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Percent Improvement
Timepoint [1] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [1] 0 0
Pain Scale
Timepoint [1] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [2] 0 0
International Knee Documentation Committee form
Timepoint [2] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [3] 0 0
Lower Extremity Function Scale
Timepoint [3] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [4] 0 0
Disabilities of the Arm, Shoulder and Hand form
Timepoint [4] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [5] 0 0
Oxford Hip Score
Timepoint [5] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [6] 0 0
Functional Rating Index
Timepoint [6] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [7] 0 0
Complications
Timepoint [7] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [8] 0 0
Adverse Events
Timepoint [8] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [9] 0 0
Number of Re-injections to treated area
Timepoint [9] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [10] 0 0
Number of Surgical Interventions to treated area
Timepoint [10] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* none

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2036
Actual
Sample size
Target
50000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Nepean Specialist Sports Medicine - Kingswood
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Vermont
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
India
State/province [21] 0 0
Telangana

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regenexx, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03011398
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Centeno, MD
Address 0 0
Regenerative Sciences, LLC and Centeno-Schultz Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03011398