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Cell Therapy
Fat Cell Injection for Knee Osteoarthritis (SVF Trial)
Phase < 1
Waitlist Available
Led By Claude T Moorman, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a single injection of a person's own fat cells to treat knee osteoarthritis after an injury.
Who is the study for?
This trial is for adults aged 18-45 who've had significant knee trauma or surgery between 1 and 20 years ago, leading to Post-Trauma Osteoarthritis (PTOA). They should have ongoing knee pain despite trying at least two treatments like medication or physical therapy. Participants need a BMI under 35, speak English, and be able to attend follow-up visits. Pregnant women, tobacco users, those with recent knee injections or certain medical conditions are excluded.
What is being tested?
The trial is testing the safety and feasibility of a single injection of autologous Adipose Derived Stromal Vascular Fraction (SVF) in treating knee PTOA. It's a before-after study conducted at two sites where participants' own processed fat tissue is used to potentially repair their injured knees.
What are the potential side effects?
While specific side effects aren't listed for SVF treatment in this summary, similar procedures may cause pain at the injection site, swelling, infection risk increase and possible allergic reactions to local anesthetics used during the procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Adverse Events
Other study objectives
General Health scores - Patient-Reported Outcomes Measurement Information System (PROMIS 29)
Knee Pain scores - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Knee Pain scores - Visual Analog Scale (VAS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF)Experimental Treatment1 Intervention
a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA)
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,460,026 Total Patients Enrolled
9 Trials studying Osteoarthritis
914 Patients Enrolled for Osteoarthritis
Claude T Moorman, MDPrincipal InvestigatorWake Forest University Health Sciences
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have painful arthritis in my hips, spine, or ankle that affects my knee's condition.I have a condition like gout, lupus, or severe knee issues.I am in good health with a BMI under 35.I am on long-term oral steroids or drugs for rheumatic diseases.I can attend all required follow-up and procedure visits.I have not had any knee injections in the last 3 months.I am not pregnant nor planning to become pregnant during the study.I have had chemotherapy or radiation on the leg or site where fat was taken for treatment.I still have knee pain after trying at least two treatments for over 3 months.I am allergic to lidocaine, epinephrine, valium, or similar sedatives.I have been diagnosed with moderate to severe arthritis due to an injury.My knee pain is due to severe cartilage damage or swelling.I have been diagnosed with chondrocalcinosis, Paget's disease, or Villonodular synovitis.I have not had knee surgery in the last 12 months.I haven't used any immunosuppressants in the last 6 weeks.I am between 18 and 45 years old and had a major knee injury or surgery due to trauma between 1 and 20 years ago.I cannot stop my blood thinner medication for an injection.I have knee pain rated above 4, and if both knees are affected, the other is not worse than 3.I am willing to stop taking pain and anti-inflammatory meds for 7 days before visits.I am willing to sign the consent and HIPAA forms for the study.I am between 18 and 45 years old and had a major knee injury or surgery due to trauma between 1 and 20 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05515523 — Phase < 1
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