Amniotic Fluid Injection for Osteoarthritis

Overseen By David Petron, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Utah

Must not be taking: Steroids, Platelet rich plasma

Disqualifiers: Diabetes, Rheumatoid arthritis, Cancer, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether injections of amniotic fluid can help people with knee osteoarthritis, a condition that causes joint pain. Participants will receive either an experimental amniotic fluid injection or a standard corticosteroid injection to compare effects. It targets individuals who have had knee osteoarthritis for over four months, experience significant pain, and haven't found relief with other treatments. As a Phase 1/Phase 2 trial, it focuses on understanding how the treatment works and measuring its effectiveness in an initial group, offering participants a chance to benefit from this innovative approach.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have used medical marijuana within 7 days of enrollment, you may not be eligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that amniotic fluid injections are generally safe. In one study, patients who received these injections, a type of tissue transplant, reported less pain and improved symptoms. Another study found no serious side effects, with many participants experiencing reduced pain and increased ability to perform daily activities a few weeks after treatment.

Some patients required a second injection because their pain did not initially decrease by at least 30%, but the treatment remained safe overall. These findings suggest that amniotic fluid injections could be a safe alternative to standard treatments like corticosteroids for osteoarthritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for osteoarthritis, which often involves corticosteroid injections to reduce inflammation, the amniotic fluid injection offers a unique approach. This treatment is derived from amniotic fluid, which contains growth factors and anti-inflammatory proteins that may promote healing and tissue regeneration. Researchers are excited because it targets the underlying causes of joint degeneration, rather than just masking symptoms. Additionally, this one-time injection could potentially provide long-lasting relief, reducing the need for repeated treatments.

What evidence suggests that amniotic fluid injection might be an effective treatment for osteoarthritis?

Research has shown that amniotic fluid injections, which participants in this trial may receive, can help with osteoarthritis. In earlier studies, patients who received these injections experienced less pain and improved mobility within six weeks, with benefits often lasting up to a year. This trial will compare amniotic fluid injections to standard steroid injections. Previous studies found that more patients experienced long-term relief with amniotic fluid compared to corticosteroids. This treatment has shown promise in reducing pain and enhancing the quality of life for individuals with joint problems. ^{1 2 3 4 6}

Who Is on the Research Team?

David Petron, MD

Principal Investigator

University of Utah Orthopaedic Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with knee osteoarthritis (Kellgren-Lawrence Stage 2-3) who can walk and have pain despite previous treatments. They must not be pregnant, nursing, or planning to become pregnant without using contraception for 90 days post-injection.

Inclusion Criteria

I have had knee pain for more than 4 months.

I have been diagnosed with moderate knee osteoarthritis.

Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection

Exclusion Criteria

Patients with known alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have used medical marijuana within 7 days of study enrollment

A focal chondral defect, defined by x-ray evaluation

I cannot consent to a form in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time injection of either amniotic fluid or corticosteroids to treat osteoarthritis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, 6, and 12 months

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Amniotic Fluid Injection
• Standard of Care

Trial Overview The study compares the effectiveness of a standard corticosteroid treatment against injections of sterile amniotic fluid in treating knee osteoarthritis. It's a Phase I/II trial where participants are randomly assigned to one of the two treatments without knowing which one they receive.

How Is the Trial Designed?

Group I: Amniotic Fluid Injection Experimental Treatment 1 Intervention

Amniotic Fluid Injection, 3ml, one time dose.

Group II: Standard of Care Steroid Injection Active Control 1 Intervention

Corticosteroids, 3ml, one time dose.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11723680/

Amniotic Tissue Injections Are an Effective Alternative to ... Both amnion and steroid injections showed an initial improvement in pain relief and function at 6 weeks; however, more patients in the amniotic ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0749806321002218

Safety and Efficacy of an Amniotic Suspension Allograft ... Treatment with ASA resulted in significant improvements in KOOS and VAS scores that were maintained through 12 months (P < .05). Treatment with ASA resulted in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02768155

Evaluation of Amniotic Fluid Product in Knee Osteoarthritis A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain.

4. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(21)00397-2/fulltext

A Single Injection of Amniotic Suspension Allograft Is Safe ... This study demonstrates promising results for relief of pain and improvement in patient-reported outcomes with intra-articular ASA in patients with moderate ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03770546

NCT03770546 | Amnion-Based Injections in the Shoulder Intra-articular amnion membrane injection may have favorable outcomes in patients with osteoarthritis of the shoulder or frozen shoulder.

6. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39575&ver=4

LCD - Amniotic and Placental Derived Product Injections ... Intermediate outcomes obtained at 24-36 weeks post-injection showed clinically relevant improvement in pain reduction and functional activities. The mean ...