Cellular Stromal Vascular Fraction (cSVF) Arm 2 for Osteoarthritis
Phase-Based Progress Estimates
Effectiveness
Safety
Hemwall Center for Orthopedic Regenerative Medicine, Valencia, CAOsteoarthritis+5 MoreCellular Stromal Vascular Fraction (cSVF) Arm 2 - Procedure
Study Summary
This trial is studying a new way to treat osteoarthritis by using a person's own stem cells and growth factors.
Eligible Conditions
- Osteoarthritis
- Osteoarthritis of the Knee
- Osteoarthritis of the Hip
- Shoulder Osteoarthritis
- Osteoarthritis of the Ankle/Foot
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 7 Secondary · Reporting Duration: Baseline, 1 month, 6 months, 1 year
6 Months
Participant with Complications
6 months
Numeric Pain Rating Scale (NPRS)
Year 1
Changes from Baseline visual analog pain scale (VAS)
Year 1
Changes in Ultrasound Images from Baseline Condition
Year 1
Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Foot and Ankle Ability Measure (FAAM)
Foot and Ankle Disability Index (FADI)
Hip Disability and OA Outcomes Survey (HOOS)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Year 1
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Year 1
Roland-Morris Back Pain Questionnaire (RMBPQ)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
tSVF + PRP + cSVF Arm 2
1 of 3
tSVF + PRP Arm1
1 of 3
Normal Saline IV + cSVF Arm 3
1 of 3
Experimental Treatment
100 Total Participants · 3 Treatment Groups
Primary Treatment: Cellular Stromal Vascular Fraction (cSVF) Arm 2 · No Placebo Group · N/A
tSVF + PRP + cSVF Arm 2Experimental Group · 3 Interventions: Tissue Stromal Vascular Fraction (tSVF) Arm 2, PRP Concentrate Arm 2, Cellular Stromal Vascular Fraction (cSVF) Arm 2 · Intervention Types: Procedure, Biological, Procedure
tSVF + PRP Arm1Experimental Group · 2 Interventions: PRP Concentrate Arm 1, Tissue Stromal Vascular Fraction (tSVF) Arm 1 · Intervention Types: Biological, Procedure
Normal Saline IV + cSVF Arm 3Experimental Group · 2 Interventions: Cellular Stromal Vascular Fraction (cSVF) Arm 3, Sterile Normal Saline (IV Solution) · Intervention Types: Procedure, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month, 6 months, 1 year
Who is running the clinical trial?
Healeon Medical IncLead Sponsor
8 Previous Clinical Trials
610 Total Patients Enrolled
Donna Alderman, DOUNKNOWN
Robert W. Alexander, MDUNKNOWN
3 Previous Clinical Trials
120 Total Patients Enrolled
Eligibility Criteria
Age 18 - 90 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Arizona | 50.0% |
| Pennsylvania | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Regenevita LLC | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
References
- Hong, Zheping, Jihang Chen, Shuijun Zhang, Chen Zhao, Mingguang Bi, Xinji Chen, and Qing Bi. 2018. “Intra-articular Injection of Autologous Adipose-derived Stromal Vascular Fractions for Knee Osteoarthritis: A Double-blind Randomized Self-controlled Trial”. International Orthopaedics. Springer Science and Business Media LLC. doi:10.1007/s00264-018-4099-0.
- Gallagher, Sean, and John R. Heberger. 2012. “Examining the Interaction of Force and Repetition on Musculoskeletal Disorder Risk”. Human Factors: The Journal of the Human Factors and Ergonomics Society. SAGE Publications. doi:10.1177/0018720812449648.
- Thorlund, J. B., C. B. Juhl, E. M. Roos, and L. S. Lohmander. 2015. “Arthroscopic Surgery for Degenerative Knee: Systematic Review and Meta-analysis of Benefits and Harms”. Bmj. BMJ. doi:10.1136/bmj.h2747.
- Alexander, Robert W.. 2016. “Biocellular Regenerative Medicine”. Physical Medicine and Rehabilitation Clinics of North America. Elsevier BV. doi:10.1016/j.pmr.2016.06.005.
- Katz, Jeffrey N., Sarah A. Brownlee, and Morgan H. Jones. 2014. “The Role of Arthroscopy in the Management of Knee Osteoarthritis”. Best Practice & Research Clinical Rheumatology. Elsevier BV. doi:10.1016/j.berh.2014.01.008.
- Albano, Joseph J, and Robert W Alexander. 2011. “Autologous Fat Grafting as a Mesenchymal Stem Cell Source and Living Bioscaffold in a Patellar Tendon Tear”. Clinical Journal of Sport Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/jsm.0b013e31821d0864.
- Nelson, Amanda E., Kelli D. Allen, Yvonne M. Golightly, Adam P. Goode, and Joanne M. Jordan. 2014. “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”. Seminars in Arthritis and Rheumatism. Elsevier BV. doi:10.1016/j.semarthrit.2013.11.012.
- Kuorinka, I., B. Jonsson, A. Kilbom, H. Vinterberg, F. Biering-Sørensen, G. Andersson, and K. Jørgensen. 1987. “Standardised Nordic Questionnaires for the Analysis of Musculoskeletal Symptoms”. Applied Ergonomics. Elsevier BV. doi:10.1016/0003-6870(87)90010-x.
- Mehranfar, Sahar, Isa Abdi Rad, Ebrahim Mostafavi, and Abolfazl Akbarzadeh. 2019. “The Use of Stromal Vascular Fraction (SVF), Platelet-rich Plasma (PRP) and Stem Cells in the Treatment of Osteoarthritis: An Overview of Clinical Trials”. Artificial Cells, Nanomedicine, and Biotechnology. Informa UK Limited. doi:10.1080/21691401.2019.1576710.
- Burdett, Nikki, and Julian David McNeil. 2012. “Difficulties with Assessing the Benefit of Glucosamine Sulphate as a Treatment for Osteoarthritis”. International Journal of Evidence-based Healthcare. Ovid Technologies (Wolters Kluwer Health). doi:10.1111/j.1744-1609.2012.00279.x.
- 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). Clin Cosm Invest Derm 6:91-102, 2013.
- Alderman, D. Regenerative injection therapies for pain: traditional, platelet-rich plasma, and biocellular prolotherapy. text, 345, 2016.
- 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.
- Lin, K., Short Review on the advancement of osteoarthritis treatment with cell therapy. J. Regen Biol Med. (2020), 2(1): 1-7.
- 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.
- 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.
- 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.
- Alexander, Robert, and David Harrell. 2013. “Autologous Fat Grafting: Use of Closed Syringe Microcannula System for Enhanced Autologous Structural Grafting”. Clinical, Cosmetic and Investigational Dermatology. Informa UK Limited. doi:10.2147/ccid.s40575.
- 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.
- 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. doi: 10.1177/0018720812449648.
- 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.
- 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.
- 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.
- 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.
- Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.
- 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.
- Albano JJ, Alexander RW. Autologous fat grafting as a mesenchymal stem cell source and living bioscaffold in a patellar tendon tear. Clin J Sport Med. 2011 Jul;21(4):359-61. doi: 10.1097/JSM.0b013e31821d0864. No abstract available.
- 2020. "Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04238143.
Frequently Asked Questions
Are my characteristics compatible with the criteria to participate in this experiment?
"For this osteoarthritis research project, 100 individuals aged 18 to 90 are being sought. Candidates must be free of systemic disorders which could jeopardise their safety; have ample donor tissue around their blood vessels and extracellular matrixes; and possess the maturity necessary to abide by treatment plans as well as fulfil post-treatment tracking requirements." - Anonymous Online Contributor
Unverified Answer
Is this clinical trial actively enrolling participants?
"Confirmed, this medical study is still seeking participants. It has been listed on clinicaltrials.gov since January 10th 2020 and was last revised in April of 2022." - Anonymous Online Contributor
Unverified Answer
What outcomes is this medical research attempting to demonstrate?
"The primary aim of this research is to evaluate the effect of Participant with Complications over Baseline, 6 months and 1 year. Secondary goals encompass assessing Foot and Ankle Disability Index (FADI) for changes in disability caused by pain and function; Knee Injury & Osteoarthritis Outcome Score (KOOS) determining knee health through gauging levels of pain from osteoarthritis; as well as Foot & Ankle Ability Measure (FAAM), which monitors shifts in discomfort, range-of-motion, and performance." - Anonymous Online Contributor
Unverified Answer
Is there an age limit to participation in this experiment?
"This research protocol is open to any individuals aged 18 and below 90." - Anonymous Online Contributor
Unverified Answer
How many people have enrolled in this medical experiment?
"Yes, the pertinent data hosted on clinicaltrials.gov confirms that recruitment for this medical study is ongoing. The information was initially posted on October 1st 2020 and most recently updated on April 7th 2022. This experiment necessitates the enrolment of 100 individuals at two distinct sites." - Anonymous Online Contributor
Unverified Answer