Examining the interaction of force and repetition on musculoskeletal disorder risk: a systematic literature review.
Sean Gallagher, John R Heberger
https://pubmed.ncbi.nlm.nih.gov/23516797/Actively Recruiting
Led by Healeon Medical Inc · Updated on 2024-10-01
100
Participants Needed
2
Research Sites
52 weeks
Total Duration
Researchers are evaluating the use of biocellular and cellular therapies derived from a persons own stemstromal cells combined with platelet-rich plasma PRP to treat osteoarthritis OA and related musculoskeletal aging, pain, and degeneration. This study aims to explore minimally invasive, non-pharmaceutical treatments to relieve OA symptoms and improve joint function, addressing the limitations of traditional surgeries and medical management. The study tracks baseline health and monitors progress over time to understand treatment impact. The trial includes three treatment approaches 1 guided biocellular therapy using tissue stromal vascular fraction tSVF plus PRP concentrate 2 combined biocellular and cellular therapy with tSVF, PRP, and cellular stromal vascular fraction cSVF and 3 cSVF delivered intravenously suspended in sterile normal saline. Treatments involve harvesting stem cells and platelets, guided placement with ultrasound, and systemic infusion. Participants receive one or more treatments, with follow-up tracking to compare outcomes from single versus multiple sites or treatments. Participants will undergo regular assessments including imaging with ultrasound and radiography, pain scales, and joint function questionnaires at baseline, 1 month, 6 months, and up to 2 years post-treatment. Researchers monitor complications, pain changes, and structural joint improvements while participants report any unexpected adverse events. The trial includes long-term follow-up to assess safety and effectiveness of these regenerative therapies for OA and connective tissue degeneration.
CONDITIONS
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
D
Donna Alderman, DO
K
Kathy Cirricione, BS
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Healeon Medical Inc
Lead Sponsor
Donna Alderman, DO
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Tissue Stromal Vascular Fraction (tSVF) and Platelet-Rich Plasma (PRP) Procedure | Tissue Stromal Vascular Fraction (tSVF), Platelet-Rich Plasma (PRP), and Cellular Stromal Vascular Fraction (cSVF) Procedure | Normal Saline (IV) and Cellular Stromal Vascular Fraction (cSVF) Procedure | Current Guideline-Supported Non-Surgical Management of Osteoarthritis |
|---|---|---|---|---|
| What is it? | Harvested tissue stromal vascular fraction (tSVF), a mix of cells from a patient’s own fat tissue, is combined with platelet-rich plasma (PRP) and then injected directly into the affected joint. | A combination of tissue stromal vascular fraction (tSVF), platelet-rich plasma (PRP), and cellular stromal vascular fraction (cSVF) is collected and then injected into the affected joint. | Cellular stromal vascular fraction (cSVF), prepared from a patient’s own fat tissue, is suspended in sterile saline and delivered intravenously. | Current guideline-supported care focuses primarily on non-surgical management such as exercise, weight management, patient education, and medications like non-steroidal anti-inflammatory drugs (NSAIDs) for symptomatic relief. |
| Role in trial | Investigational therapy tested for its impact on osteoarthritis symptoms and joint condition. | Investigational therapy tested for its effect on joint pain and function in osteoarthritis. | Investigational therapy to assess safety and any improvement in osteoarthritis symptoms. | Not part of the trial; shown for context as the usual recommended care outside clinical studies. |
| Primary use | Intended to reduce joint pain and inflammation and improve mobility in osteoarthritis. | Aims to relieve symptoms and improve joint function for people with osteoarthritis. | Investigational; designed to test if cSVF given by IV plus saline can affect osteoarthritis symptoms. | Non-surgical treatments mainly manage pain, swelling, and function to maintain quality of life in osteoarthritis. |
| How is it given or performed? | The procedure involves harvesting fat tissue using a sterile microcannula, isolating tSVF, preparing PRP from blood, and injecting both into the joint. | Fat tissue is harvested, tSVF and cSVF are isolated, PRP is prepared, and all are injected into the affected joint. | After isolation, cSVF is suspended in sterile normal saline and delivered by intravenous (IV) infusion. | Non-surgical guideline care involves regular exercise, education, weight control, pain medications, and sometimes joint injections with corticosteroids or hyaluronic acid. |
| Evidence status | Early clinical research including case series and small trials suggests possible benefit for joint pain, but definitive large-scale evidence is lacking and results are mixed. | Very limited published evidence available for this complex combination; use remains investigational, and effectiveness is unproven outside research settings. | Clinical research into IV cSVF for osteoarthritis is limited, and there is no established external evidence supporting efficacy. | Non-surgical guideline care (exercise, NSAIDs, education, weight management, and joint injections) is supported by high-quality evidence for improvement in pain and function in osteoarthritis. |
| Important limitations | Availability outside trials may be limited, and potential risks or benefits are still being studied; evidence for long-term outcomes is incomplete. | Even less is known about safety, risks, or outcomes with this mixed technique; access to this therapy outside research is highly restricted. | Unproven intervention with unknown clinical utility; not standard care and not available in usual practice. | Non-surgical care may not halt disease progression and individual response to medications or activity modifications can vary; long-term adherence to lifestyle changes is challenging. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive one of three regenerative therapy approaches involving harvesting and preparation of cellular and biocellular products, which are then guided into affected joints or delivered intravenously.
1 treatment visit (in-person)
Duration - Minimum 2 years
Participants are followed and monitored over a minimum of two years to track progress, adverse events, and imaging changes after treatment.
Visits at baseline, 1 month, 6 months, 1 year, and ongoing follow-ups up to 2 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/23630430/Healeon Medical Inc
Lead Sponsor
Donna Alderman, DO
Collaborating Sponsor