What side effects are associated with this type of intervention?

Common treatments for osteoarthritis similar to the Hyalofast® scaffold with bone marrow aspirate concentrate include intraarticular injections of hyaluronic acid derivatives and platelet-rich plasma (PRP). Known side effects of these treatments include a small risk of infection, pain, bleeding, tenderness, swelling, and bruising at the injection site. Additionally, there is a rare risk of acute postinjection flare, termed pseudoseptic reaction, which involves effusion and inflammation without infection. These side effects are generally minor and transient.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, primarily focusing on pain relief and inflammation reduction. These include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and hyaluronic acid injections. While treatments like the Hyalofast® scaffold with bone marrow aspirate concentrate, which provide a scaffold for tissue growth and deliver stem cells and growth factors, are still under investigation, they represent a promising area of regenerative medicine aimed at cartilage repair. Currently, no specific FDA-approved treatments directly match the regenerative approach of Hyalofast®.

What other types of research exist?

Promising novel alternatives for osteoarthritis treatment in 2024 include: 1) Sprifermin (rhFGF-18), a recombinant human fibroblast growth factor that has shown potential in increasing cartilage thickness. 2) Autologous chondrocyte implantation (ACI), which involves harvesting and culturing a patient's own cartilage cells before re-implanting them into the joint. 3) Mesenchymal stem cell (MSC) therapy, which uses stem cells derived from bone marrow, adipose tissue, or umbilical cord to promote cartilage repair and reduce inflammation. These alternatives are in various stages of clinical trials and have shown encouraging results in terms of safety and efficacy.

← Back to Search

Scaffold

Hyalofast + Microfracture for Knee Cartilage Repair (FastTRACK Trial)

N/A

Waitlist Available

Led By Alberto Gobbi, MD

Research Sponsored by Anika Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has a minimum of 45 out of 100 Visual Analogue Scale (VAS) score for index knee pain when remembering index knee pain when not on medication and when active

Patient is male or female, between 18 and 60 years of age

Must not have

Patient requiring concomitant surgical procedures at the time of Index Procedure such as osteotomies (e.g. high tibial valgus and/or patellar realignment osteotomy), bone subchondral perforation, ligament surgery, meniscal surgeries etc.

Previous cartilage repair procedure (microfracture, Osteochondral autograft transplantation system (OATS) or Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for knee cartilage damage using a special pad and concentrated bone marrow cells from the patient. It aims to help patients whose knee cartilage causes symptoms and may not respond to usual treatments. The pad supports the bone marrow cells to heal and regenerate the damaged area. Bone marrow concentrate (BMC) has shown promise in treating knee issues and cartilage repair due to its regenerative potential.

Who is the study for?

Adults aged 18-60 with a BMI under 35 and knee pain from cartilage damage in the femoral condyle or trochlea, sized 1.5 - 6 cm2, graded ICRS 3 or 4. Participants must be able to follow a strict rehab protocol, not use certain pain meds for six months post-surgery except NSAIDs or acetaminophen, and meet specific health criteria like normal blood counts.

What is being tested?

The trial is testing Hyalofast scaffold with bone marrow aspirate concentrate (BMAC) against microfracture surgery for treating knee cartilage defects. It aims to see which method is safer and more effective at relieving symptoms and repairing the damaged area.

What are the potential side effects?

Potential side effects may include discomfort at the site where bone marrow is taken (for BMAC), reaction to materials used in scaffolds, surgical risks like infection or bleeding, joint stiffness or swelling after treatment, and general anesthesia risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My knee pain scores at least 45 out of 100 when active and not on medication.

Select...

I am between 18 and 60 years old.

Select...

I have a painful knee lesion confirmed by a radiologist to be 1.5 - 6 cm2 in size.

Select...

I agree to only use NSAIDs or acetaminophen for pain after 6 months post-surgery until the trial ends.

Select...

My cartilage damage is severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need additional surgeries like bone or ligament surgery at the time of my main procedure.

Select...

I've had a previous cartilage repair in my knee.

Select...

I have had a meniscal transplant in my knee before.

Select...

I have a serious nerve or blood vessel problem in my legs that affects my daily life.

Select...

My knee condition is not caused by infections, inflammation, genetic disorders, or specific diseases like gout or Paget's.

Select...

I have rheumatoid arthritis or gout.

Select...

My knee arthritis is severe, as shown by a high grade on a specific scale.

Select...

My target knee is free from infections or skin diseases.

Select...

I have been diagnosed with osteochondritis dissecans.

Select...

I cannot have microfracture surgery due to health reasons.

Select...

I don't have any painful conditions in my spine, hips, or legs that would affect my knee's evaluation.

Select...

I have been diagnosed with a bone infection.

Select...

I am at high risk for bleeding or infection after surgery due to a condition or medication.

Select...

My diabetes is not under control.

Select...

My knee is significantly bent inward or outward.

Select...

I need surgery for a torn meniscus using stitches or arrows.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Superiority of Hyalofast with Bone Marrow Aspirate Concentrate (BMAC) vs. Microfracture for % Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score

Superiority of Hyalofast with Bone Marrow Aspirate Concentrate (BMAC) vs. Microfracture for % Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hyalofast with BMACExperimental Treatment1 Intervention

A hyaluronan-based scaffold (Hyalofast®) is utilized together with autologous bone marrow aspirate concentrate (BMAC) in a one-step arthroscopic/mini-arthrotomic procedure.

Group II: MicrofractureActive Control1 Intervention

Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair.

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Osteoarthritis (OA) include NSAIDs and glucocorticoids, which primarily provide symptomatic relief by reducing inflammation and pain but do not halt disease progression. More advanced treatments, such as the Hyalofast® scaffold with bone marrow aspirate concentrate (BMAC), aim to repair cartilage by providing a structural scaffold that supports tissue growth and delivers mesenchymal stem cells (MSCs) and growth factors to the affected area. These MSCs have the potential to differentiate into chondrocytes, the cells responsible for cartilage formation, thereby promoting cartilage repair and potentially improving joint function. This approach is significant for OA patients as it addresses the underlying cartilage damage rather than just alleviating symptoms, offering a more comprehensive treatment strategy.

Editorial Commentary: Biological Cartilage Repair Technique-An "Effective, Accessible, and Safe" Surgical Solution for an Old Difficult Biological Problem.One-Stage Cartilage Repair Using a Hyaluronic Acid-Based Scaffold With Activated Bone Marrow-Derived Mesenchymal Stem Cells Compared With Microfracture: Five-Year Follow-up.Bone Marrow Aspirate in the Treatment of Chondral Injuries.