Amniotic Suspension Allograft for Knee Osteoarthritis

Not currently recruiting at 41 trial locations

Overseen By Brittany Fry

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Organogenesis

Must not be taking: Anticoagulants, Immunosuppressives, Steroids

Disqualifiers: Knee surgery, Infection, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Amniotic Suspension Allograft (ASA) to determine its effectiveness and safety for people with knee osteoarthritis (OA), a condition causing joint pain and stiffness. Participants will receive either the ASA treatment or a placebo (a harmless substance resembling the treatment but without active ingredients) to compare outcomes. It suits individuals diagnosed with knee OA who have tried at least two other treatments without success in the past year and experience significant knee pain affecting daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for knee OA.

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

The trial protocol does not specify if you need to stop taking your current medications, but you cannot use pain medication less than 5 days before the baseline visit or regularly use anticoagulants. It's best to discuss your specific medications with the trial team.

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

Research has shown that Amniotic Suspension Allograft (ASA) is generally safe for people. In a study comparing ASA to a saltwater solution for treating knee osteoarthritis, ASA led to better results without major safety issues. Specifically, 63.2% of participants reported relief after 12 months. Importantly, this study found no serious side effects linked to ASA, suggesting that ASA is a safe option for managing knee osteoarthritis symptoms. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for knee osteoarthritis?

Unlike standard treatments for knee osteoarthritis, which often include NSAIDs, corticosteroid injections, or hyaluronic acid, the Amniotic Suspension Allograft (ASA) is derived from amniotic fluid. This gives it unique regenerative properties that might help repair and cushion knee cartilage. Researchers are excited because ASA could potentially offer longer-lasting relief and promote healing rather than just masking pain. Additionally, its single injection approach could simplify treatment compared to multiple doses required by other therapies.

What evidence suggests that Amniotic Suspension Allograft might be an effective treatment for knee osteoarthritis?

Research has shown that Amniotic Suspension Allograft (ASA), which participants in this trial may receive, can help people with knee osteoarthritis by reducing pain and improving joint function. In one study, patients who received ASA reported less pain and increased activity for up to 12 months after treatment. Another review found ASA effective in reducing pain and improving movement in people with knee osteoarthritis. Animal studies also showed positive results, suggesting ASA might help repair joint damage. Overall, these findings support ASA's potential as an effective treatment for knee osteoarthritis symptoms. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with a BMI under 40 and moderate to severe knee osteoarthritis, who haven't responded well to other treatments for at least six months. Participants must not be on immunosuppressives or have recent knee injuries/surgeries, infections, or conditions that could affect safety or data quality. They should use birth control if applicable.

Inclusion Criteria

I have tried at least two osteoarthritis treatments in the past year without success.

I have been diagnosed with osteoarthritis in my knee based on symptoms and X-rays.

Have you failed to adequately respond for at least 6 months to at least two therapies within the last 12 months for the treatment of OA [Note: this includes acetaminophen, exercise, weight loss, physical therapy, NSAIDS (oral or topical), or corticosteroids]

Exclusion Criteria

I do not have any infections, including in my knee, or skin issues around my knee.

I had fluid removed from my knee due to swelling in the last 3 months.

I have not had knee surgery in the past year and do not plan to during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of ASA or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Multiple visits (in-person and virtual) for assessments

What Are the Treatments Tested in This Trial?

Interventions

• Amniotic Suspension Allograft
• Placebo

Trial Overview The trial is testing the effectiveness of Amniotic Suspension Allograft (ASA) against a placebo in reducing knee pain from osteoarthritis. Patients will randomly receive either ASA or an inactive substance to compare outcomes.

How Is the Trial Designed?

Group I: ASA Experimental Treatment 1 Intervention

Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)

Group II: Placebo Placebo Group 1 Intervention

Participants receive a single IA injection of 4 mL of normal saline

Amniotic Suspension Allograft is already approved in United States for the following indications:

Approved in United States as Amniomatrix for:

• Wound healing
• Osteoarthritis symptoms management

Who Is Running the Clinical Trial?

Organogenesis

Lead Sponsor

Trials

37

Recruited

4,400+

Published Research Related to This Trial

In a multicenter randomized controlled trial involving 200 subjects with knee osteoarthritis, amniotic suspension allograft (ASA) treatment resulted in significantly greater improvements in pain and function compared to both hyaluronic acid (HA) and saline treatments over 3 and 6 months.

Only 13.2% of patients receiving ASA reported unacceptable pain at 3 months, compared to 68.8% in the HA group and 75% in the saline group, indicating ASA's potential as an effective nonoperative management option for symptomatic knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. Farr, J., Gomoll, AH., Yanke, AB., et al.[2020]

A feasibility study involving 6 patients with severe knee osteoarthritis showed that a single injection of human amniotic suspension allografts (ASA) was safe, with no significant adverse reactions or effects on blood cell counts and inflammatory markers over 12 months.

Patient-reported outcomes indicated a potential benefit from the ASA treatment, supporting the need for a larger placebo-controlled trial to further evaluate its efficacy in managing symptoms of knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. Vines, JB., Aliprantis, AO., Gomoll, AH., et al.[2017]

In a study involving 95 patients with moderate knee osteoarthritis who previously failed treatment with hyaluronic acid or saline, a single injection of amniotic suspension allograft (ASA) led to significant improvements in pain and function over 12 months, as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS).

The treatment was found to be safe, with no severe adverse events reported, and over 55% of patients were classified as responders at 3, 6, and 12 months, indicating that ASA can be an effective option for patients who did not respond to previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Initial Injection and a Crossover Injection of Amniotic Suspension Allograft Following Failed Treatment with Hyaluronic Acid or Saline Are Equally Effective in the Treatment of Moderate Symptomatic Knee Osteoarthritis Over 12 Months. Gomoll, AH., Mandelbaum, BR., Farr, J., et al.[2023]

In a study using a rat model of osteoarthritis, treatment with amniotic suspension allograft (ASA) significantly improved pain thresholds and reduced weight-bearing aversion and swelling, indicating its potential as an effective anti-inflammatory treatment.

The ASA treatment led to increased levels of the anti-inflammatory cytokine IL-10 in synovial fluid, suggesting a mechanism by which ASA may exert its therapeutic effects in osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic Suspension Allograft Modulates Inflammation in a Rat Pain Model of Osteoarthritis. Kimmerling, KA., Gomoll, AH., Farr, J., et al.[2020]

In a rat model of knee osteoarthritis, injections of amniotic suspension allograft (ASA) significantly improved pain thresholds, gait, and overall function, indicating its potential efficacy as a nonsurgical treatment.

The study found that ASA treatment led to increased cartilage thickness and anti-inflammatory cytokines without causing adverse effects, suggesting it is a safe option for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic suspension allograft improves pain and function in a rat meniscal tear-induced osteoarthritis model. Kimmerling, KA., Gomoll, AH., Farr, J., et al.[2022]

In a pilot study involving 25 patients with knee osteoarthritis, a single intra-articular injection of human amniotic suspension allograft (HASA) was found to be safe, with no severe complications reported during treatment or follow-up.

The study demonstrated statistically significant improvements in knee symptoms at 3, 6, and 12 months post-injection, suggesting that HASA could be an effective minimally invasive treatment option for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Amniotic Suspension Allograft Improves Pain and Function in Knee Osteoarthritis: A Prospective Not Randomized Clinical Pilot Study. Natali, S., Farinelli, L., Screpis, D., et al.[2022]

Citations

1. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(22)00411-X/fulltext

An Initial Injection and a Crossover Injection of Amniotic ... The purpose of this crossover study was to determine the efficacy of amniotic suspension allograft (ASA) for moderate symptomatic knee ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9599686/

Amniotic Suspension Allograft for Treatment of Knee ... Several preclinical studies, as discussed earlier [1], have shown positive outcomes in rat and rabbit OA models [15,16,17,18,19]. Despite these ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04636229

Efficacy of Amniotic Suspension Allograft in Patients With ... This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

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

Safety and Efficacy of an Amniotic Suspension Allograft ... Treatment of symptomatic knee OA with an ASA resulted in significant improvements out to 12 months in the KOOS subscales and VAS scores compared to HA and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39793609/

Efficacy of Amniotic Suspension Allografts in the Treatment ... This systematic review evaluated the efficacy and safety of ASA in reducing pain and improving function among knee osteoarthritis patients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33716121/

Safety and Efficacy of an Amniotic Suspension Allograft ... This randomized controlled trial of ASA vs HA and saline for the treatment of symptomatic knee osteoarthritis demonstrated clinically meaningful improved ...

7. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT04636229

Amniotic Suspension Allograft in Patients With Osteoarthritis of ... This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms ...