Stem Cell and Growth Factor Therapy for Osteoarthritis

(GARM-MSK-ALD Trial)

Recruiting at 1 trial location

Overseen By Kathy Cirricione, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Healeon Medical Inc

Must not be taking: Steroids, Opiates

Disqualifiers: Active cancer, Pregnancy, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating osteoarthritis (OA) using a person's own stem cells combined with growth factors from their blood. The goal is to find long-term, minimally invasive treatments to ease pain and improve joint function, avoiding surgery or medications. Participants will join different groups to try combinations of these treatments, including Cellular Stromal Vascular Fraction (cSVF) and Tissue Stromal Vascular Fraction (tSVF), to determine which works best. The trial seeks individuals with osteoarthritis in joints like the knee, hip, or shoulder, who experience noticeable pain or movement issues. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could significantly improve the quality of life for OA patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who have used high-dose steroids or corticosteroids within six months before the treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial—Tissue Stromal Vascular Fraction (tSVF), Cellular Stromal Vascular Fraction (cSVF), and Platelet-Rich Plasma (PRP)—are generally safe for people.

For the combination of tSVF and PRP, studies have found these treatments are usually well-tolerated. Some patients might feel minor discomfort at the injection site, but no serious side effects have been reported.

When tSVF, PRP, and cSVF are used together, research indicates a similar safety level. Various studies have used this combination safely, with no serious issues reported by patients.

Using cSVF alone has also proven safe. Many studies suggest it can help with joint problems without causing serious side effects.

Overall, while some minor side effects might occur, current research considers these treatments safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard osteoarthritis treatments, which often include pain relievers and anti-inflammatory drugs, these investigational therapies utilize stem cell approaches to target the condition at its source. Cellular Stromal Vascular Fraction (cSVF) and Tissue Stromal Vascular Fraction (tSVF) contain regenerative cells that may potentially repair damaged tissues rather than just alleviating symptoms. The addition of Platelet-Rich Plasma (PRP) in some treatment arms could enhance healing by releasing growth factors that accelerate tissue repair. Researchers are excited about these treatments because they offer a regenerative approach, which might provide more sustainable relief and possibly reverse joint damage over time.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research has shown that using Stromal Vascular Fraction (SVF) with Platelet-Rich Plasma (PRP) can improve joint movement and reduce pain in knee osteoarthritis. In this trial, participants in the tSVF + PRP arm may experience benefits, as studies have found that combinations like tSVF + PRP can outperform standard treatments in healing tissue and easing symptoms. Another arm in this trial, which includes tSVF + PRP + cSVF, might offer further improvements in pain and movement, although some studies report mixed results regarding its overall effectiveness. For participants in the cSVF alone arm, research has reported significant improvements in pain and movement over time for patients with mild to moderate osteoarthritis. Overall, these treatments show promise for providing long-term relief from osteoarthritis symptoms without requiring major surgery. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with documented osteoarthritis who can follow treatment and tracking instructions. They must have enough donor tissue for the procedure, understand the consent form, and not have any systemic disorders that would make the procedures unsafe. People with active cancer, infections, drug addiction or severe brain injuries, pregnant women, high dose steroid users within six months before treatment are excluded.

Inclusion Criteria

No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures

I have enough healthy tissue for donation.

I can follow treatment and post-treatment instructions.

Exclusion Criteria

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

I am not currently dealing with drug addiction or in rehab.

I do not have any infections that could make treatment risky for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guided biocellular therapy using tSVF and PRP, with some receiving additional cSVF concentrates or cSVF only via systemic deployment

6 months

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up extending over a two-year period

2 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Cellular Stromal Vascular Fraction (cSVF)
• PRP Concentrate
• Sterile Normal Saline (IV Solution)
• Tissue Stromal Vascular Fraction (tSVF)

Trial Overview The study tests minimally invasive treatments using a patient's own stem cells plus HD-PRP to treat osteoarthritis without pharmaceuticals or traditional surgery. It compares different combinations of Tissue Stromal Vascular Fraction (tSVF), Cellular Stromal Vascular Fraction (cSVF), PRP Concentrate and saline solution in three arms.

How Is the Trial Designed?

Group I: tSVF + PRP Arm1 Experimental Treatment 2 Interventions

Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate

Group II: tSVF + PRP + cSVF Arm 2 Experimental Treatment 3 Interventions

Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)

Group III: Normal Saline IV + cSVF Arm 3 Experimental Treatment 2 Interventions

Cellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction

Cellular Stromal Vascular Fraction (cSVF) is already approved in United States for the following indications:

Approved in United States as Autologous Adipose-Derived Mesenchymal Stem Cells for:

• Osteoarthritis (OA) of the knee

Who Is Running the Clinical Trial?

Healeon Medical Inc

Lead Sponsor

Trials

9

Recruited

710+

Donna Alderman, DO

Collaborator

Trials

1

Recruited

100+

Robert W. Alexander, MD

Collaborator

Trials

4

Recruited

220+

Published Research Related to This Trial

Mechanically derived stromal vascular fraction (tSVF) shows promise as a treatment for osteoarthritis by stimulating chondrocyte proliferation and preserving their function, based on in vitro studies.

tSVF significantly reduces inflammation in TNFα-stimulated chondrocytes, indicating its potential as an anti-inflammatory therapy for osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanically Derived Tissue Stromal Vascular Fraction Acts Anti-inflammatory on TNF Alpha-Stimulated Chondrocytes In Vitro. van Boxtel, J., Vonk, LA., Stevens, HP., et al.[2023]

Intra-articular injections of autologous stromal vascular fraction (SVF) significantly improved knee osteoarthritis symptoms, with high-dose patients showing an 89.5% improvement in WOMAC scores after 12 months compared to 0% in the placebo group.

The study, involving 39 patients in a randomized controlled trial, demonstrated that the improvements were dose-dependent and no serious adverse events were reported, indicating both efficacy and safety for SVF as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Garza, JR., Campbell, RE., Tjoumakaris, FP., et al.[2020]

The study successfully standardized the preparation of adipose-derived stromal vascular fraction (SVF) from New Zealand white rabbits, achieving an average cell yield of 3.15 million cells per gram of adipose tissue, which is higher than previous methods.

Using enzymatic digestion with 0.1% collagenase not only improved cell yield but also eliminated the need for additional culture periods, making the process safer and more cost-effective for applications in bone tissue engineering.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization and characterization of adipose-derived stromal vascular fraction from New Zealand white rabbits for bone tissue engineering. Sharun, K., Pawde, AM., Kumar, R., et al.[2022]

The study demonstrated that injecting autologous adipose-derived stromal vascular cells (SVF) into osteoarthritic knees is safe, with no reported adverse events such as infections or pain flares in 6 patients treated over a year.

Patients experienced significant pain reduction and improved function, as shown by better scores on the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3 months and maintained these improvements at 1 year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Fodor, PB., Paulseth, SG.[2022]

In a study involving rabbits with bone defects, using adipose-derived stromal vascular fractions (SVF) significantly improved bone healing compared to a control group that only received a scaffold, indicating the potential of SVF in bone tissue engineering.

Osteogenically differentiated SVF cells were found to enhance bone healing even more than undifferentiated SVF cells, suggesting that the differentiation of these cells can lead to better outcomes in bone repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of rabbit ulna segmental bone defect using freshly isolated adipose-derived stromal vascular fraction. Kim, A., Kim, DH., Song, HR., et al.[2018]

Adipose-derived stromal vascular fraction (tSVF) shows promising therapeutic efficacy, particularly in treating conditions like osteoarthritis and wound healing, based on a review of studies involving 1465 patients and 410 animals.

Mechanical fractionation methods, especially those involving centrifugation, are effective for isolating tSVF, which is crucial for maximizing its clinical benefits, although the specific preparation method does not significantly affect its therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical Fractionation of Adipose Tissue-A Scoping Review of Procedures to Obtain Stromal Vascular Fraction. Schipper, JAM., van Laarhoven, CJHCM., Schepers, RH., et al.[2023]

In a study involving 421 patients, the administration of autologous stromal vascular fraction (SVF) mixed with platelet-rich plasma (PRP) was found to be safe, with no major adverse events reported, even at doses up to 10 billion SVF cells for intravenous injections.

Adverse events were minor and primarily associated with spinal or intra-articular injections, indicating that the SVF and PRP themselves were not responsible for these issues, suggesting a favorable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. Karina, K., Rosliana, I., Rosadi, I., et al.[2022]

Intra-articular injection of adipose-derived stromal vascular fraction (SVF) cells in 57 patients with knee osteoarthritis showed significant improvements in knee extension and pain scores over a 12-month follow-up period, indicating its efficacy as a treatment.

The treatment led to better clinical outcomes, as measured by the WOMAC, VAS, and KOOS scores, with no significant changes in the hip-knee-ankle angle, suggesting that SVF cell therapy is a promising and innovative approach for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of adipose-derived stromal vascular fraction cells on the treatment of knee osteoarthritis. Tsubosaka, M., Matsumoto, T., Sobajima, S., et al.[2021]

The first clinical use of stromal vascular fraction (SVF) was successfully implemented in a patient with severe psoriasis, showing significant improvement in skin quality and a reduction in psoriasis severity from a score of 50.4 to 0.3 within one month.

The treatment was safe, with no reported adverse events over a 12-month monitoring period, suggesting that SVF could be a promising and feasible option for psoriasis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-man intravenous implantation of stromal vascular fraction in psoriasis: a case study. Comella, K., Parlo, M., Daly, R., et al.[2023]

The stromal vascular fraction (SVF) derived from adipose tissue has been shown to be safe and effective in various therapeutic applications, demonstrating strong anti-inflammatory and reparative effects in living organisms.

The effectiveness of SVF is linked to its diverse cellular composition, which includes adipose-derived stem cells and various immune cells, highlighting its potential in regenerative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolation and Flow Cytometric Analysis of the Stromal Vascular Fraction Isolated from Mouse Adipose Tissue. Bowles, AC., Tucker, A., Bunnell, BA.[2019]

The study involved 676 patients receiving stromal vascular fraction (SVF) injections for various degenerative diseases, demonstrating a strong safety profile with very few mild and transient adverse events reported, such as soreness and headaches.

The procedure, which involves isolating stem cells from adipose tissue through a minimally invasive liposuction technique, shows promise as a safe autologous stem cell therapy, with any reported deaths likely unrelated to the treatment itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction. Comella, K., Parlo, M., Daly, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11145973/

Efficacy of stromal vascular fraction for knee osteoarthritis Our study demonstrates that SVF therapy provides notable functional and pain improvement for patients with mild to moderate knee OA. In comparison to the short- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9386815/

Stromal vascular fraction therapy for knee osteoarthritis found that SVF treatment improved pain and functionality since a reduction in the mean VAS (from 5.1; SD: 1.2 at 12 months to 3.4; SD: 1.8 at 24 months) and ...

3. jocmr.org jocmr.org/index.php/JOCMR/article/view/4354

A Retrospective Study of Stromal Vascular Fraction Cell ... Results: Seven days after SVF cell therapy, 45.2% of subjects experienced improved pain levels and mobility. Three, 6, and 12 months after therapy, improvement ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352320425000495

Comparison of short-term clinical outcomes of intra ... This study aimed to compare the clinical outcomes of SVF and MFAT for knee OA, focusing on their therapeutic effects over time.

5. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-022-02788-1

Mid-term prognosis of the stromal vascular fraction for ... Up to 5 years after SVF treatment, acceptable clinical state was present for approximately 60% of patients. BML severity and BMI were independent predictors of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01885832

Safety and Feasibility Study of Autologous Stromal ... Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity will be safe and feasible as ...

7. landerurology.com landerurology.com/wp-content/uploads/2022/07/4-Safety-of-stromal-vascular-fraction-cells-applications-in-chronic-pain.pdf

Safety of stromal vascular fraction cells applications in ... The shared research collaborative online database contains safety and efficacy data on more than 3500 patients. Our processed SVF contains valuable anti- ...

8. liebertpub.com liebertpub.com/doi/full/10.1089/scd.2024.0008

Clinical Evaluation of Safety and Efficacy of a Central ... Stromal vascular fraction (SVF) is a heterogenous, autologous cell product, containing mesenchymal stem cells, derived from the patient's subcutaneous adipose ...