Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
GARM-MSK-ALD
1 other identifier
interventional
100
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2020
CompletedFirst Submitted
Initial submission to the registry
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
October 1, 2024
September 1, 2024
6.7 years
January 13, 2020
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Participant with Complications
Adverse and Severe Adverse Events
6 Months
Numeric Pain Rating Scale (NPRS)
Subjective Pain Rating
6 months
Changes from Baseline visual analog pain scale (VAS)
Patient Reported Pain (1-10)
Baseline, 1 month, 6 months, 1 year
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 Outcomes (7)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline; 6 Month; 1 year
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Baseline; 6 Month; 1 Year
Hip Disability and OA Outcomes Survey (HOOS)
Baseline; 6 Month; 1 Year
Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Baseline; 6 Month; 1 Year
Roland-Morris Back Pain Questionnaire (RMBPQ)
Baseline; 6 months; 1 year
- +2 more secondary outcomes
Study Arms (3)
tSVF + PRP Arm1
EXPERIMENTALTissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate
tSVF + PRP + cSVF Arm 2
EXPERIMENTALTissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)
Normal Saline IV + cSVF Arm 3
EXPERIMENTALCellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction
Interventions
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
Preparation of PRP Concentrate via sterile Terumo-Harvest System
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
Preparation of PRP Concentrate via sterile Terumo-Harvest System
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healeon Medical Inclead
- Donna Alderman, DOcollaborator
- Robert W. Alexander, MDcollaborator
Study Sites (2)
Hemwall Center for Orthopedic Regenerative Medicine
Valencia, California, 91355, United States
Regenevita LLC
Stevensville, Montana, 59870, United States
Related Publications (18)
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.
BACKGROUNDAlexander 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.
PMID: 23630430BACKGROUNDAlbano 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.
PMID: 21562415BACKGROUNDLin, K., Short Review on the advancement of osteoarthritis treatment with cell therapy. J. Regen Biol Med. (2020), 2(1): 1-7.
BACKGROUNDMehranfar 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.
PMID: 30887856BACKGROUNDHong 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.
PMID: 30109404BACKGROUNDAlderman, D. Regenerative injection therapies for pain: traditional, platelet-rich plasma, and biocellular prolotherapy. text, 345, 2016.
BACKGROUNDAlexander 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.
PMID: 27788905RESULTNelson 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.
PMID: 24387819RESULTAlderman, D, Alexander, RW, Stem Cell Prolotherapy In Regenerative Medicine: Background, Theory, and Protocols. J. Prolo 3(3): 689-708, 2011.
RESULTAlexander, 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.
RESULTBurdett 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.
PMID: 22925619RESULTThorlund 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.
PMID: 26080045RESULTKatz 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.
PMID: 24792949RESULTAlderman, D, Alexander, RW. Advances In Regenerative Medicine: High Density Platelet-Rich Plasma and Stem Cell Prolotherapy. J. Prac Pain Management, Oct: 49-60, 2011.
RESULTAlexander, 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.
RESULTGallagher 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.
PMID: 23516797RESULTKuorinka 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.
PMID: 15676628RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2020
First Posted
January 23, 2020
Study Start
January 10, 2020
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2027
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share