SyntrFuge™-Processed Adipose Tissue for Knee Osteoarthritis

Recruiting at 1 trial location

Overseen By Ahmed Zobi, EMBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Syntr Health Technologies, Inc.

Must not be taking: Anticoagulants, NSAIDs, Corticosteroids, others

Disqualifiers: Osteonecrosis, Gout, Inflammatory arthritis, others

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

Compensation: Varies

Number of Visits: 25

Duration: 1 day

176 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites or Standard of Care.

Will I have to stop taking my current medications?

You may need to stop taking certain medications like blood thinners, anti-inflammatory drugs, or substances that affect blood clotting for 7 days before and 3 days after the injection. A washout period (time without taking certain medications) of 7 days is allowed. Please consult with the study team for specific guidance on your medications.

What data supports the effectiveness of the treatment SyntrFuge System, Autologous Microsized Adipose Tissue Therapy for knee osteoarthritis?

Research shows that using microfragmented adipose tissue (a type of fat tissue) for knee osteoarthritis can help reduce pain and improve joint function. Studies have found that this treatment can support tissue healing and provide long-lasting relief from symptoms. ^{1 2 3 4 5}

Is SyntrFuge-Processed Adipose Tissue safe for treating knee osteoarthritis?

Studies show that using processed adipose (fat) tissue for knee osteoarthritis is generally safe, with no adverse effects reported in patients up to one year after treatment. ^{2 5 6 7 8}

How is the SyntrFuge System treatment different from other treatments for knee osteoarthritis?

The SyntrFuge System treatment is unique because it uses a patient's own adipose (fat) tissue, processed to create a microsized form, which is then injected into the knee to help reduce pain and support tissue regeneration. This approach leverages the regenerative potential of adipose-derived cells, offering a novel alternative to traditional surgical or pharmaceutical treatments. ^{2 6 7 9 10}

Eligibility Criteria

This trial is for adults aged 35-80 with moderate to severe knee osteoarthritis. Participants must be in good health, not pregnant or nursing, and have a BMI between 20 and 34.9. They should be able to walk and commit to the study schedule. Exclusions include uncontrolled diseases, recent immunosuppressive therapy, coagulation disorders, current drug/alcohol abuse, recent other treatments for osteoarthritis or participation in another study.

Inclusion Criteria

I am not pregnant or breastfeeding.

Written Authorization for Use and Release of Health and Research Study Information has been signed

My knee arthritis is moderate to severe.

Exclusion Criteria

Subjects planning to become pregnant, are pregnant, or are breast-feeding

I have been diagnosed with osteonecrosis.

Subjects with history or current evidence of drug or alcohol abuse within 36 months prior to screening visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either adipose tissue processed with the SyntrFuge™ system or standard of care treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Multiple visits over 24 months

Treatment Details

Interventions

• SyntrFuge System

Trial Overview The trial tests the SyntrFuge™ System's effectiveness on knee osteoarthritis by comparing adipose tissue processed with this system followed by an injection of microsized adipose tissue against standard care practices.

Participant Groups

Group I: SyntrFuge System Experimental Treatment 1 Intervention

Adipose tissue microsized via the SyntrFuge System

Group II: Standard of Care Experimental Treatment 1 Intervention

Steroid Injection

Who Is Running the Clinical Trial?

Syntr Health Technologies, Inc.

Lead Sponsor

Trials

3

Recruited

240+

Findings from Research

A systematic review of 12 clinical trials showed that minimally manipulated autologous lipoaspirate injections significantly reduced pain and improved joint function in patients with knee osteoarthritis, indicating potential efficacy for regenerative treatment.

Despite the positive outcomes, the studies varied in quality and assessment methods, suggesting a need for better standardization in protocols and devices to enhance the reliability and effectiveness of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipoaspirate processing for the treatment of knee osteoarthritis: a review of clinical evidences. Lavagnolo, U., Veronese, S., Negri, S., et al.[2021]

In a study of 110 knees, a single ultrasound-guided injection of microfragmented adipose tissue (MFAT) significantly reduced pain (VAS score improved from 70 to 30) and enhanced functionality (OKS score improved from 25 to 33.5) in patients with knee osteoarthritis over a 12-month period.

No adverse events were reported during or after the procedure, indicating that MFAT injections are a safe treatment option for knee osteoarthritis, with promising improvements in patient quality of life (EQ-5D score improved from 0.62 to 0.69).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months. Heidari, N., Noorani, A., Slevin, M., et al.[2022]

In a study involving 118 patients with knee osteoarthritis, both microfragmented adipose tissue (MF-AT) and platelet-rich plasma (PRP) injections led to significant improvements in knee function and pain relief over 24 months, with no notable differences in outcomes between the two treatments.

While MF-AT and PRP showed similar efficacy, a higher percentage of patients with moderate to severe OA in the MF-AT group achieved clinically meaningful improvements in knee function at 6 months, suggesting a potential advantage for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfragmented Adipose Tissue Versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Prospective Randomized Controlled Trial at 2-Year Follow-up. Zaffagnini, S., Andriolo, L., Boffa, A., et al.[2023]

In a randomized controlled trial involving 78 patients with knee osteoarthritis, the combination of microfragmented adipose tissue (mFAT) and arthroscopic debridement (AD) significantly improved functional scores compared to AD alone at both 6 months and 24 months follow-up.

The mFAT treatment also resulted in better MRI outcomes, indicating enhanced tissue healing, and was associated with lower T2-mapping scores in knee compartments, suggesting improved cartilage health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial. Ulivi, M., Meroni, V., Viganò, M., et al.[2023]

A single injection of autologous micro-fragmented adipose tissue (MF-AT) significantly improved knee function and reduced pain in patients with knee osteoarthritis over an 18-month period, with the most notable improvements seen at 9-12 months post-injection.

No adverse events were reported during the study, indicating that MF-AT is a safe treatment option; however, the benefits in knee function were not sustained beyond 12 months, and further research is needed to assess long-term cartilage regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Injection of Autologous Micro-Fragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: A Prospective Interventional Study. Yu, Y., Lu, Q., Li, S., et al.[2023]

In a study involving 87 patients with knee osteoarthritis, a single injection of concentrated autologous adipose tissue significantly reduced pain and improved knee function, with 67 patients reporting pain relief.

The treatment was generally safe, with no major adverse effects reported, although some patients experienced mild swelling post-injection and five required knee replacement surgery within months of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of knee osteoarthritis by intra-articular injection of concentrated autologous adipose tissue: a twenty four month follow-up study. Bistolfi, A., Roato, I., Fornelli, G., et al.[2021]

The study evaluated a novel surgical technique using 3D bioprinted micronized adipose tissue grafts for treating full thickness cartilage defects in knee osteoarthritis, involving 10 patients monitored for 12 months.

Results showed significant improvements in patient-reported outcomes (WOMAC and KOOS scores) and complete incorporation of the grafts into surrounding cartilage, indicating both efficacy and a favorable safety profile for this innovative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Evaluation of Cartilage Regeneration Efficacy of Three-Dimensionally Biofabricated Human-Derived Biomaterials on Knee Osteoarthritis: A Single-Arm, Open Label Study in Egypt. Abdelhamid, MM., Eid, G., Othman, MHM., et al.[2023]

Intra-articular injection of autologous purified adipose tissue significantly reduced pain in knee osteoarthritis patients, with a 53% decrease after 1 month and an 83% decrease after 1 year, based on VAS scores.

The treatment also led to a 47% improvement in functional recovery after 1 month and an 84% improvement after 1 year, with no reported adverse effects, indicating both safety and efficacy over a 12-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Administration of Autologous Purified Adipose Tissue Associated with Arthroscopy Ameliorates Knee Osteoarthritis Symptoms. Caforio, M., Nobile, C.[2021]

Adipose tissue is increasingly being used by orthopedic surgeons as a valuable resource for treating osteoarthritis due to its abundance and accessibility, providing both cells and scaffolds for regenerative applications.

The regulatory landscape for using adipose tissue in orthopedic surgery is complex, necessitating a thorough understanding of FDA guidelines and recent clinical literature on its efficacy in treating osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-homologous use of adipose-derived cell and tissue therapies: Osteoarthritis as a case study. Frazier, T., March, K., Garza, JR., et al.[2023]

Adipose tissue-derived mesenchymal stem cells (ASCs) can be effectively cultured in methacrylated gelatin (GelMA) constructs, maintaining high cell viability and adipogenic potential over 28 days, which is crucial for studying knee osteoarthritis (OA).

The study demonstrates that these ASCs can be used in a 3D organ-on-a-chip system to model the infrapatellar fat pad (IPFP) in the knee joint, providing a valuable tool for investigating the inflammatory role of adipose tissue in OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose Tissue-Derived Stem Cells Retain Their Adipocyte Differentiation Potential in Three-Dimensional Hydrogels and Bioreactors †. O'Donnell, BT., Al-Ghadban, S., Ives, CJ., et al.[2021]

References

1. France pubmed.ncbi.nlm.nih.gov

Lipoaspirate processing for the treatment of knee osteoarthritis: a review of clinical evidences. [2021]

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

Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months. [2022]

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

Microfragmented Adipose Tissue Versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Prospective Randomized Controlled Trial at 2-Year Follow-up. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial. [2023]

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

Intra-Articular Injection of Autologous Micro-Fragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: A Prospective Interventional Study. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Treatment of knee osteoarthritis by intra-articular injection of concentrated autologous adipose tissue: a twenty four month follow-up study. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Evaluation of Cartilage Regeneration Efficacy of Three-Dimensionally Biofabricated Human-Derived Biomaterials on Knee Osteoarthritis: A Single-Arm, Open Label Study in Egypt. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Intra-Articular Administration of Autologous Purified Adipose Tissue Associated with Arthroscopy Ameliorates Knee Osteoarthritis Symptoms. [2021]

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

Non-homologous use of adipose-derived cell and tissue therapies: Osteoarthritis as a case study. [2023]

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

Adipose Tissue-Derived Stem Cells Retain Their Adipocyte Differentiation Potential in Three-Dimensional Hydrogels and Bioreactors †. [2021]