What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as autologous adipose-derived SVF injections, PRP, and MSCs, generally have minor and transient side effects. These can include pain, bleeding, tenderness, swelling, and bruising at the injection site. There is also a risk of local infection associated with intraarticular injections. For MSCs, additional concerns include the high cost and prolonged manufacturing process. Glucocorticoid injections, while providing short-term pain relief, are not recommended for routine use due to potential adverse effects with frequent administration.

What other types of research exist?

Promising novel alternatives to Autologous Adipose-Derived SVF Injection for osteoarthritis treatment include Platelet-Rich Plasma (PRP) therapy, which has shown mixed but generally positive results in improving joint function and reducing pain. Additionally, bone marrow-derived mesenchymal stem cells (BM-MSCs) have demonstrated potential in tissue repair and inflammation reduction. Another emerging option is the use of intra-articular injections of growth factors or cytokine inhibitors, such as sprifermin, which has shown efficacy in reducing cartilage loss and promoting cartilage gain. Patients should discuss these options with their healthcare provider to determine the most appropriate treatment based on their specific condition and medical history.

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Cell Therapy

Fat Cell Injection for Knee Osteoarthritis

Q: What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, primarily focusing on pain management and inflammation reduction. These include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and hyaluronic acid injections. While there are no specific FDA approvals for autologous adipose-derived stromal vascular fraction (SVF) injections, similar regenerative therapies like platelet-rich plasma (PRP) have been explored for their potential in reducing inflammation and promoting tissue repair. However, the efficacy and safety of these biologic therapies are still under investigation, and they are often used within the context of clinical trials.

N/A

Recruiting

Research Sponsored by GID BIO, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment 1 day

Follow Up 12 months

Summary

This trial tests if injecting special cells from a patient's own fat can reduce pain and improve function in people with knee osteoarthritis. These cells have been investigated in various studies for their potential to treat knee osteoarthritis by reducing pain and improving function.

Who is the study for?

This trial is for men and women aged 35-85 with knee osteoarthritis who've tried at least two treatments without success, including physical therapy or injections. They must not have had recent major knee injuries, surgery, or certain other joint conditions. Participants need to understand English, be able to attend follow-up visits, and have a BMI between 22 and 37.

What is being tested?

The study tests the safety and effectiveness of a single injection using autologous adipose-derived SVF produced by the GID SVF-2 device system in reducing pain and improving function in patients with knee osteoarthritis.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical risks associated with injections such as pain at the injection site, infection risk, allergic reactions to components like lidocaine or epinephrine used during the procedure.

Timeline

Screening ~ 3 weeks1 visit

Treatment ~ 1 day1 visit

Follow Up ~ 12 months4 visits

Screening ~ 3 weeks

Treatment ~ 1 day

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, 1 day for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Western Ontario and McMaster Universities Arthritis Index

Secondary study objectives

Adverse Events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Stromal Vascular Fraction (SVF)Experimental Treatment1 Intervention

Subjects will receive an injection of Stromal Vascular Fraction in their index knee

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive an injection of Lactated Ringers in their index knee

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Regenerative therapies for osteoarthritis, such as autologous adipose-derived stromal vascular fraction (SVF) injections and platelet-rich plasma (PRP), work by utilizing the body's own cells to promote healing and reduce inflammation. SVF contains a mixture of cells, including mesenchymal stem cells, which can differentiate into various cell types and release anti-inflammatory cytokines, aiding in tissue repair and reducing joint inflammation. PRP, derived from the patient's blood, is rich in growth factors that stimulate cell proliferation and tissue regeneration while also modulating the inflammatory response. These mechanisms are crucial for osteoarthritis patients as they offer potential relief from pain and improved joint function by addressing the underlying causes of tissue degeneration and inflammation.