Amniotic Suspension Allograft for Osteoarthritis

Recruiting at 36 trial locations

Overseen By Adam Yanke, MD, PhD

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

474 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Amniotic Suspension Allograft for osteoarthritis?

Research shows that Amniotic Suspension Allograft (ASA) can significantly reduce pain and improve function in patients with knee osteoarthritis. In a study, patients receiving ASA reported greater improvements in pain and daily activities compared to those receiving other treatments like hyaluronic acid or saline. ^{1 2 3 4 5}

Is Amniotic Suspension Allograft safe for humans?

Studies on Amniotic Suspension Allograft for knee osteoarthritis show it is generally safe, with no severe complications reported during treatment and follow-up periods. ^{1 2 4 5 6}

How does the amniotic suspension allograft treatment differ from other treatments for osteoarthritis?

Amniotic suspension allograft (ASA) is unique because it uses placental-derived tissues that provide growth factors and anti-inflammatory agents, potentially reducing inflammation and promoting tissue regeneration in osteoarthritis. Unlike other treatments, ASA has shown greater improvements in pain and function compared to hyaluronic acid and saline, making it a promising non-surgical option for knee osteoarthritis. ^{1 2 4 5 7}

What is the purpose of this trial?

This trial is testing a new treatment called ASA, which is injected directly into the knee joint. It aims to help patients with knee osteoarthritis by reducing pain and improving joint function. The study will compare the effects of ASA over several months.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 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

Findings from Research

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. [2017]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Amniotic Suspension Allograft Modulates Inflammation in a Rat Pain Model of Osteoarthritis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Amniotic suspension allograft improves pain and function in a rat meniscal tear-induced osteoarthritis model. [2022]

5. Germany 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. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Human Amniotic Suspension Allograft Improves Pain and Function in Knee Osteoarthritis: A Prospective Not Randomized Clinical Pilot Study. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Amniotic Tissue Modulation of Knee Pain-A Focus on Osteoarthritis. [2019]