Osteoarthritis Clinical Trial
— GARM-MSK-ALDOfficial title:
Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures. This study is to use a person's own stem/stromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | July 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Documented osteoarthritic inflammatory and/or degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or Plantar Fasciitis (PR); - No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures; - Have the ability to understand and accept all items in Informed Consent Document; - Have adequate perivascular and extracellular matrix donor tissues available; - Mature enough to tolerate determined procedures and follow up instructions and complete post-treatment tracking responsibilities Exclusion Criteria: - Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking; - Known active cancer, chemotherapy, or radiation therapy; - Pregnancy; - Active infections which would increase risk of patient to undergo treatment; - High dose steroid users, or recipients of corticosteroids with a six month period before treatment date; - Medication or Opiate addition, or in active treatment for drug rehabilitation; - History of documented severe traumatic brain injuries; - In the opinion of the principal investigator/provider, the patient's condition or medical issues which would not allow the individual to fully accomplish or complete the study requirements |
Country | Name | City | State |
---|---|---|---|
United States | Regenevita LLC | Stevensville | Montana |
United States | Hemwall Center for Orthopedic Regenerative Medicine | Valencia | California |
Lead Sponsor | Collaborator |
---|---|
Healeon Medical Inc | Donna Alderman, DO, Robert W. Alexander, MD |
United States,
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Alderman, D, Alexander, RW, Stem Cell Prolotherapy In Regenerative Medicine: Background, Theory, and Protocols. J. Prolo 3(3): 689-708, 2011.
Alderman, D, Alexander, RW. Advances In Regenerative Medicine: High Density Platelet-Rich Plasma and Stem Cell Prolotherapy. J. Prac Pain Management, Oct: 49-60, 2011.
Alderman, D. Regenerative injection therapies for pain: traditional, platelet-rich plasma, and biocellular prolotherapy. text, 345, 2016.
Alexander RW, Harrell DB. Autologous fat grafting: use of closed syringe microcannula system for enhanced autologous structural grafting. Clin Cosmet Investig Dermatol. 2013 Apr 8;6:91-102. doi: 10.2147/CCID.S40575. Print 2013. — View Citation
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, RW, Overview of Cellular Stromal Vascular Fraction (cSVF) & Biocellular Uses of Stem/Stromal Cells & Matrix (tSVF + HD-PRP) in Regenerative Medicine, Aesthetic Medicine, and Plastic Surgery. J Stem Cell Res Ther; S1003, 2019.
Alexander, RW. Understanding Adipose-Derived Stromal Vascular Fraction (SVF) Cell Biology On The Basis of Perivascular Cell Components In Aesthetic & Regenerative Medicine. J. Prolo, 4: e13777, 2012.
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
Hong Z, Chen J, Zhang S, Zhao C, Bi M, Chen X, Bi Q. Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial. Int Orthop. 2019 May;43(5):1123-1134. doi: 10.1007/s00264-018-4099-0. Epub 2018 Aug 14. — 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
Lin, K., Short Review on the advancement of osteoarthritis treatment with cell therapy. J. Regen Biol Med. (2020), 2(1): 1-7.
Mehranfar S, Abdi Rad I, Mostafav E, Akbarzadeh A. The use of stromal vascular fraction (SVF), platelet-rich plasma (PRP) and stem cells in the treatment of osteoarthritis: an overview of clinical trials. Artif Cells Nanomed Biotechnol. 2019 Dec;47(1):882-890. doi: 10.1080/21691401.2019.1576710. Review. — 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 Rhe — 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. Prolotherapy; 5:e895-912, 2013.
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 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant with Complications | Adverse and Severe Adverse Events | 6 Months | |
Primary | Numeric Pain Rating Scale (NPRS) | Subjective Pain Rating | 6 months | |
Primary | Changes from Baseline visual analog pain scale (VAS) | Patient Reported Pain (1-10) | Baseline, 1 month, 6 months, 1 year | |
Primary | Changes in Ultrasound Images from Baseline Condition | High Definition Ultrasonography Soft and Hard Tissues of Musculoskeletal Areas To Be Treated | Baseline, 6 months, 1 year | |
Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Measure Knee and OA Status for Pain and OA | Baseline; 6 Month; 1 year | |
Secondary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Measure Change from Baseline of Pain and Arthritis In Knee and Hip | Baseline; 6 Month; 1 Year | |
Secondary | Hip Disability and OA Outcomes Survey (HOOS) | Measure Change from Baseline of Pain & Function of Hip | Baseline; 6 Month; 1 Year | |
Secondary | Disabilities of the Arm, Shoulder, and Hand Score (DASH) | Measure Change from Baseline of Pain, Range of Motion and Function All Areas | Baseline; 6 Month; 1 Year | |
Secondary | Roland-Morris Back Pain Questionnaire (RMBPQ) | Measure Change from Baseline of Pain, Function and Range of Motion | Baseline; 6 months; 1 year | |
Secondary | Foot and Ankle Ability Measure (FAAM) | Measure Change from Baseline Pain, Function, Range of Motion | Baseline; 6 Month; 1 Year | |
Secondary | Foot and Ankle Disability Index (FADI) | Measure Change in Disability From Baseline Pain, Function, Range of Motion | Baseline; 6 Month; 1 Year |
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