Osteoarthritis Clinical Trial
— BRTOfficial title:
Use of Cellular and Biocellular Therapy in Musculoskeletal Pain, Dysfunction, Degenerative or Inflammatory Disease
Musculoskeletal disorders and degeneration represent injuries or pain in the body's joint
ligaments, tendons, muscles, nerves, and skeletal elements that support extremities, spine
and related tissues. Direct injuries and aging contribute to breakdown and inflammation of
these tissues, leading to debilitation and loss of function in these areas. This has major
impact on quality of life, occupational/recreation limitations, and psychosocial
implications.
Many therapies have been employed including medications, physical therapy, occupational
therapy, and a variety of surgical interventions each of which have distinct limitations,
often covering the issues versus providing actual healing and return to function. Many
reports are now available utilizing self-healing options which include use of stem/stromal
cellular therapy or biocellular treatments (either from adipose or marrow) using targeted
placement of cells, matrix and platelet concentrates. Termed cellular or Biocellular therapy
(typically optimized using ultrasound guidance). It is proposed that use of cellular isolates
or cell-stroma derived from the largest deposit of these cells (adipose greater than marrow),
may use in conjunction with targeted placement or as a stand alone methodology intravascular
use.
This study is designed as a interventional means to examine the safety and efficacy of the
use of cellular and tissue stromal vascular fraction in musculoskeletal pain, dysfunction
degeneration or inflammatory disorders.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Patients with documented inflammatory, autoimmune (rheumatoid arthritis (RA), degeneration of musculoskeletal system - No systemic disorders which, in the opinion of the principal investigators or provider, would disqualify from being safely able to undergo needed procedures - Able to provide informed consent - Patient having adequate donor adipose (fat) tissue - Patient mature enough to tolerate the needed procedures Exclusion Criteria: - Systemic or psychological impairment which would preclude patient tolerance and understanding of procedures and follow up - Patients with known active cancer and chemotherapy or radiation therapy - Patients with ongoing active infections - High dose steroid users or use of injections of corticoid steroids within a six month timeframe - Opiate addition or in treatment program for withdrawal - History of severe traumatic brain injuries - If, in the opinion of providers, the patient will not be able to fully cooperate or complete the study and its follow up |
Country | Name | City | State |
---|---|---|---|
United States | Regeneris Medical | North Attleboro | Massachusetts |
United States | Regeneris Medical | North Attleboro | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Robert W Alexander, MD | Global Alliance for Regenerative Medicine, Regeneris Medical |
United States,
Alderman, D, Alexander, R.W.,: Advances In Regenerative Medicine: High Density Platelet-Rich Plasma and Stem Cell Prolotherapy. J Pract Pain Management, 2011; Vol Oct: 49-90
Alexander RW. Biocellular Regenerative Medicine: Use of Adipose-Derived Stem/Stromal Cells and It's Native Bioactive Matrix. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):871-891. doi: 10.1016/j.pmr.2016.06.005. Review. — View Citation
Alexander, Robert W., Understanding Adipose-Derived Stromal Vascular Fraction (SVF) Cell Biology On The Basis of Perivascular Cell Components In Aesthetic and Regenerative Medicine. J. Prolo; 2012; 4: e13777
Alexander, Robert W., Understanding Mechanical Emulsification (NanoFat) Versus Enzymatic Isolation fo Tissue Stromal Vascular Fraction (tSVF) From Adipose Tissue: Potential Uses in Biocellular Regenerative Medicine. J of Prolo. 2016; 8: 3947-960.
Alexander, Robert W., Use of Disposable Microcannula System For Low Pressure Harvest, Preparation, and Placement of Small Volume Autologous Fat Grafting With Activated High Density Platelet-Rich Plasma (HD-PRP). Clinical Cosmetic and Investigational Dermatology. 2013: 6: 91-102.
Burdett N, McNeil JD. Difficulties with assessing the benefit of glucosamine sulphate as a treatment for osteoarthritis. Int J Evid Based Healthc. 2012 Sep;10(3):222-6. doi: 10.1111/j.1744-1609.2012.00279.x. Review. — View Citation
Gallagher S, Heberger JR. Examining the interaction of force and repetition on musculoskeletal disorder risk: a systematic literature review. Hum Factors. 2013 Feb;55(1):108-24. Review. — View Citation
Katz JN, Brownlee SA, Jones MH. The role of arthroscopy in the management of knee osteoarthritis. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):143-56. doi: 10.1016/j.berh.2014.01.008. Review. — View Citation
Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sørensen F, Andersson G, Jørgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. — View Citation
Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4. Review. — View Citation
Oliver, K., Alexander, RW. Combination of Autologous Adipose-Derived Tissue Stromal Vascular Fraction Plus High Density Platelet-Rich Plasma or Bone Marrow Concentrates in Achilles Tendon Tears. J. Prolo; 2013; 5: e895-912.
Thorlund JB, Juhl CB, Roos EM, Lohmander LS. Arthroscopic surgery for degenerative knee: systematic review and meta-analysis of benefits and harms. BMJ. 2015 Jun 16;350:h2747. doi: 10.1136/bmj.h2747. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants with complications | Adverse and Severe Adverse Events Reports | 1 month | |
Secondary | Change from baseline quality of life level (QoL Questionnaire) | QoL Questionnaire | 6 months, 12 months | |
Secondary | Change from baseline visual analog pain score | Changes of Visual Analog Pain Score (VAS) 1-10 | 6 months, 1 year, 2 year | |
Secondary | Change from baseline of limitation of activities (Functional analysis of range of motion) | Functional analysis of range of motion compared from baseline | baseline, 6 months, 1 year | |
Secondary | Change from baseline of imaging if required for study entry | imaging | baseline, 1 year |
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