100 Participants Needed

Stem Cell and Growth Factor Therapy for Osteoarthritis

(GARM-MSK-ALD Trial)

Recruiting at 1 trial location
DA
KC
Overseen ByKathy Cirricione, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Healeon Medical Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12678

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.3491011

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.
See 4 more

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.
See 5 more

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
3Treatment groups
Experimental Treatment
Group I: tSVF + PRP Arm1Experimental Treatment2 Interventions
Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate
Group II: tSVF + PRP + cSVF Arm 2Experimental Treatment3 Interventions
Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)
Group III: Normal Saline IV + cSVF Arm 3Experimental Treatment2 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

Find a Clinic Near You

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

References

Repair of rabbit ulna segmental bone defect using freshly isolated adipose-derived stromal vascular fraction. [2018]
Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. [2022]
Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. [2022]
Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction. [2023]
Mechanical Fractionation of Adipose Tissue-A Scoping Review of Procedures to Obtain Stromal Vascular Fraction. [2023]
Standardization and characterization of adipose-derived stromal vascular fraction from New Zealand white rabbits for bone tissue engineering. [2022]
First-in-man intravenous implantation of stromal vascular fraction in psoriasis: a case study. [2023]
Isolation and Flow Cytometric Analysis of the Stromal Vascular Fraction Isolated from Mouse Adipose Tissue. [2019]
The influence of adipose-derived stromal vascular fraction cells on the treatment of knee osteoarthritis. [2021]
Mechanically Derived Tissue Stromal Vascular Fraction Acts Anti-inflammatory on TNF Alpha-Stimulated Chondrocytes In Vitro. [2023]
11.United Statespubmed.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]
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