Amniotic Suspension Allograft for Knee Osteoarthritis

Recruiting at40 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Organogenesis

Must not be taking: Anticoagulants, Immunosuppressives, Steroids

Disqualifiers: Knee surgery, Infection, Substance use, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if injecting ASA into the knee can help people with knee osteoarthritis feel better. The study will check pain levels, knee function, and safety over several months. ASA (Amniotic Suspension Allograft) has been shown to be an effective treatment for knee osteoarthritis in previous studies.

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.

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

Research shows that Amniotic Suspension Allograft (ASA) can reduce pain and improve function in knee osteoarthritis. In a study, patients receiving ASA reported better pain relief and daily activity scores 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. Some studies noted no significant injection reactions or changes in blood markers, although there was a small increase in certain antibodies, which are proteins that help fight infections. ^{1 2 4 5 6}

How is the amniotic suspension allograft treatment different from other treatments for knee osteoarthritis?

The amniotic suspension allograft (ASA) is unique because it uses placental-derived tissues that provide growth factors and cytokines, which can reduce inflammation and promote tissue regeneration in the knee. Unlike other treatments, ASA is administered as a single intra-articular injection, offering a minimally invasive option that has shown promising results in improving pain and function in knee osteoarthritis patients. ^{1 2 4 5 6}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Amniotic Suspension Allograft (Other)
• Placebo (Other)

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.

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

Who Is Running the Clinical Trial?

Organogenesis

Lead Sponsor

Trials

37

Recruited

4,400+

Findings from Research

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 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 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]

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 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. 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]

2. 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]

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

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

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]