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

Trial Summary

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.

What data supports the effectiveness of this treatment for osteoarthritis?

Research indicates that stromal vascular fraction (SVF) from adipose tissue, which includes stem cells, can reduce inflammation and promote healing in degenerative diseases like osteoarthritis. Studies have shown positive outcomes in osteoarthritis treatment using SVF, suggesting it may help repair damaged tissue and improve symptoms. ^{1 2 3 4 5}

Is stem cell and growth factor therapy for osteoarthritis safe?

Research shows that stromal vascular fraction (SVF) therapy, which includes stem cells from fat tissue, has been used safely in over 421 patients for various conditions, with no major safety concerns reported. ^{1 2 6 7 8}

How is the treatment using Cellular Stromal Vascular Fraction (cSVF) and Tissue Stromal Vascular Fraction (tSVF) for osteoarthritis different from other treatments?

This treatment is unique because it uses a patient's own fat tissue to extract a mixture of cells, including stem cells, which are then injected into the affected joint to reduce inflammation and promote healing. Unlike other treatments, it involves a minimally invasive procedure to obtain these cells, and it leverages the body's natural healing processes without the need for synthetic drugs. ^{3 4 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Repair of rabbit ulna segmental bone defect using freshly isolated adipose-derived stromal vascular fraction. [2018]

2. Egypt pubmed.ncbi.nlm.nih.gov

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Canada 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Mechanical Fractionation of Adipose Tissue-A Scoping Review of Procedures to Obtain Stromal Vascular Fraction. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Standardization and characterization of adipose-derived stromal vascular fraction from New Zealand white rabbits for bone tissue engineering. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

First-in-man intravenous implantation of stromal vascular fraction in psoriasis: a case study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Isolation and Flow Cytometric Analysis of the Stromal Vascular Fraction Isolated from Mouse Adipose Tissue. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The influence of adipose-derived stromal vascular fraction cells on the treatment of knee osteoarthritis. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Mechanically Derived Tissue Stromal Vascular Fraction Acts Anti-inflammatory on TNF Alpha-Stimulated Chondrocytes In Vitro. [2023]

11. United States 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. [2020]