Amniotic Suspension Allograft for Osteoarthritis

No longer recruiting at 36 trial locations

Overseen By Adam Yanke

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Organogenesis

Must not be taking: NSAIDs, Anticoagulants, Corticosteroids, others

Disqualifiers: Knee surgery, Immunosuppressive therapy, 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: Unknown

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 in reducing knee pain and improving symptoms for people with osteoarthritis (OA). The researchers aim to assess whether ASA is more effective and safe compared to a placebo (a substance with no active therapeutic effect). Participants will receive an injection directly into the knee to evaluate its impact on OA symptoms. This trial may suit those diagnosed with knee OA who have not found relief from at least two other treatments, such as pain relievers or physical therapy, for at least six months. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial requires you to stop using pain medications like NSAIDs and CBD oil at least 15 days before treatment, but acetaminophen is allowed. Regular use of anticoagulants and certain other treatments for the knee are also not permitted. If you're on any of these, you may need to stop them to participate.

Is there any evidence suggesting that Amniotic Suspension Allograft is likely to be safe for humans?

Research shows that Amniotic Suspension Allograft (ASA) may be a promising treatment for knee osteoarthritis. Studies have found that ASA is generally safe for patients. In one study, 63.2% of patients responded positively to ASA after 12 months, indicating its likely safety. Patients also reported less pain and improved knee function. While these results are promising, discussing potential risks with a doctor before joining a clinical trial is important. ^{1 2 3 4 5}

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

Unlike the typical treatments for osteoarthritis, which often involve pain relievers or anti-inflammatory medications, the Amniotic Suspension Allograft (ASA) offers a novel approach. ASA is derived from amniotic fluid, which is rich in growth factors and anti-inflammatory properties that may promote healing and reduce joint inflammation directly. This treatment is particularly exciting because it is administered as a single intra-articular injection, potentially providing relief with fewer doses compared to ongoing medication regimens. Researchers are hopeful that ASA could offer a more regenerative and less invasive option for managing osteoarthritis symptoms.

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

Research has shown that Amniotic Suspension Allograft (ASA), which participants in this trial may receive, might help treat knee osteoarthritis. In one study, 63.2% of patients felt better after using ASA for 12 months, with more than half experiencing symptom relief. Animal studies also suggest positive results. Additionally, a small study found that a single ASA injection was safe and helped reduce pain and improve movement. These findings suggest ASA could be a promising treatment for osteoarthritis symptoms. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with knee osteoarthritis, a BMI under 40, and pain not relieved by standard treatments can join. They must have tried at least two therapies for six months without success. Women should be postmenopausal or use contraception; men agree to contraception if not sterile. No recent corticosteroid injections in the knee, no significant other illnesses, and no substance abuse.

Inclusion Criteria

Diagnosis of OA of the knee by a combination of clinical and radiographic findings

Your pain score on the WOMAC Pain scale for the past 7 days is 11 or higher.

Body mass index (BMI) < 40 kg/m²

Exclusion Criteria

You have received a corticosteroid injection in your knee within the past 3 months before the screening.

Your screening tests or physical examination show important health issues that are not specifically related to knee osteoarthritis. These issues could affect the study or make it harder to understand the results, or they may increase your risk as a participant.

You have received injections or treatments for your knee within the past 6 months, such as hyaluronic acid, platelet-rich plasma, or other substances derived from your own body or from others.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

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

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amniotic Suspension Allograft
• Placebo

Trial Overview

The trial is testing Amniotic Suspension Allograft (ASA), a new treatment for knee osteoarthritis symptoms against a placebo. Participants will receive either ASA or an inactive substance to compare effectiveness and safety.

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+

Premier Research

Collaborator

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD

Published Research Related to This Trial

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 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]

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]

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]

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 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]

Citations

1.

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 ...

2.

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.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0749806321002218

Safety and Efficacy of an Amniotic Suspension Allograft ...

Treatment with ASA resulted in a 63.2% responder rate at 12 months using the Outcome Measures in Arthritis Clinical Trials–Osteoarthritis Research Society ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9224721/

Human Amniotic Suspension Allograft Improves Pain and ...

The present pilot study indicates that a single intra-articular injection of HASA seems safe and able to provide positive clinical outcomes.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06000410

A Study to Evaluate the Efficacy of Amniotic Suspension ...

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.

6.

arthroscopyjournal.org

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

An Initial Injection and a Crossover Injection of Amniotic ...

An initial injection and a crossover injection of amniotic suspension allograft following failed treatment with hyaluronic acid or saline are equally effective.

7.

pubmed.ncbi.nlm.nih.gov

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

Safety and Efficacy of an Amniotic Suspension Allograft ...

Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS) score, were collected ...