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Cell Therapy
Fat Cell Injection for Knee Osteoarthritis
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 days
Follow Up 12 months
Awards & highlights
Summary
This trial will test a new treatment for osteoarthritis pain that involves injecting fat cells into the knee joint.
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.Check my eligibility
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.See study design
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 days1 visit
Follow Up ~ 12 months4 visits
Screening ~ 3 weeks
Treatment ~ 1 days
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Western Ontario and McMaster Universities Arthritis Index
Secondary outcome measures
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
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.
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
GID BIO, Inc.Lead Sponsor
4 Previous Clinical Trials
64 Total Patients Enrolled
1 Trials studying Osteoarthritis
39 Patients Enrolled for Osteoarthritis
William Cimino, PhDStudy ChairGID BIO
Media Library
Awards:
This trial has 0 awards, including:Other Trials to Consider
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