Osteochondral Allografts for Knee Defects

Recruiting at 5 trial locations

Overseen By Paige McHenry, MS, ATC, CCRA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: AlloSource

Must not be taking: Corticosteroids, Hyaluronic acid

Disqualifiers: Obesity, Cancer, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: Immediate procedure

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Cryopreserved Osteochondral Allograft Core, which uses preserved donor tissue, to determine its effectiveness in healing knee defects on the femoral condyle, part of the knee joint. The goal is to provide evidence of its effectiveness for individuals who have not found relief with other treatments and continue to experience significant knee pain. Suitable candidates for this trial have a moderate to severe knee cartilage defect, have tried other treatments without success, and are scheduled for a specific type of knee surgery, known as osteochondral transplant.

As an unphased trial, it offers patients the opportunity to explore a novel treatment option that could potentially alleviate persistent knee pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently using oral corticosteroids or have received certain injections recently, you may not be eligible to participate.

What prior data suggests that cryopreserved osteochondral allograft cores are safe for treating knee defects?

Research has shown that cryopreserved osteochondral allograft cores, which are special tissue grafts, are generally safe for patients. In one study, patients observed for up to two years after receiving these grafts reported good results without negative side effects, indicating safety during that period.

Additionally, studies on similar fresh allografts, which are not frozen, have demonstrated long-term safety. These fresh grafts have lasted well over many years. While researchers continue to study the frozen versions, the positive results from fresh allografts provide insight into their safety.

In simpler terms, using these frozen tissue grafts in the knee appears safe, with no problems reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for knee defects, such as microfracture surgery or autologous chondrocyte implantation, cryopreserved osteochondral allograft cores offer a unique approach by using donor tissue to repair damaged cartilage and bone. This method provides a more natural and potentially longer-lasting solution because it incorporates living cartilage cells that can integrate with the patient's own tissue. Researchers are excited about this treatment because it may lead to improved joint function and pain relief, offering hope for patients with significant cartilage damage who have limited options.

What evidence suggests that Cryopreserved Osteochondral Allograft Cores might be an effective treatment for knee defects?

Research has shown that using frozen donor tissue, such as the cryopreserved osteochondral allograft cores studied in this trial, can effectively treat knee problems. Patients with knee cartilage issues have reported positive results at least two years after receiving this treatment. In one study, patients experienced significant improvements in knee function and overall quality of life, with some scores more than doubling. These encouraging results suggest that the treatment helps repair damaged knee cartilage, potentially leading to better movement and less pain. Overall, this treatment appears to be a promising option for those with knee joint issues. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 12-60 with moderate to severe knee pain due to cartilage damage on the femoral condyle, unresponsive to other treatments. Candidates must have stable knees or be able to stabilize them during surgery and intact menisci or correctable malalignment.

Inclusion Criteria

My knee pain is severe and hasn't improved with medication, therapy, or surgery.

My knee's cushioning is mostly intact or slightly trimmed but stable.

My knee alignment is normal or will be corrected to less than 5° off.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or more cryopreserved osteochondral allograft core transplants to replace damaged cartilage

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

8 visits (in-person) at 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Cryopreserved Osteochondral Allograft Cores

Trial Overview The study tests the effectiveness of Cryopreserved Osteochondral Allograft Cores in treating osteochondral lesions on the femoral condyle by transplanting these cores into patients' knees.

How Is the Trial Designed?

Group I: Osteochondral transplant on the femoral condyle Experimental Treatment 1 Intervention

Eligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure

Who Is Running the Clinical Trial?

AlloSource

Lead Sponsor

Trials

10

Recruited

700+

Published Research Related to This Trial

Fresh osteochondral allograft (OCA) transplantation is an effective single-stage procedure for treating knee cartilage defects, showing reliable long-term improvements in patient outcomes and graft survival.

Using fresh precut OCA cores for smaller lesions allows for quicker treatment without the complications of donor site morbidity, making it a practical alternative to traditional grafting methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh Precut Osteochondral Allograft Core Transplantation for the Treatment of Femoral Cartilage Defects. Jones, KJ., Mosich, GM., Williams, RJ.[2020]

In a study of 19 patients treated with fresh osteochondral allografts for knee defects, significant improvements in functional outcomes were observed, with scores on the Activities of Daily Living Scale and Short Form-36 increasing notably after an average follow-up of 48 months.

The study found that fresh allografts stored for 17 to 42 days were effective in maintaining cartilage structure and function, with most grafts showing preserved cartilage thickness and positive correlations between graft incorporation and functional scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh stored allografts for the treatment of osteochondral defects of the knee. Williams, RJ., Ranawat, AS., Potter, HG., et al.[2022]

Fresh osteochondral allografts have shown over 75% clinical success in treating various knee joint issues, including trauma and chondral injuries, making them a reliable option for patients.

These allografts are particularly beneficial for younger, active individuals who may not be suitable candidates for joint replacement surgery, and ongoing improvements in the procedure and understanding of their biology are expected to enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh osteochondral allografts. Bugbee, WD.[2022]

The novel cryopreserved viable osteochondral allograft (CVOCA) retains viable chondrocytes and essential growth factors, which are crucial for cartilage repair, and shows improved outcomes in a goat model when combined with marrow stimulation.

Histological analysis confirmed that the CVOCA preserves the architecture of native hyaline cartilage, enhancing mesenchymal stem cell migration and chondrogenesis, leading to better cartilage repair compared to marrow stimulation alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel, cryopreserved, viable osteochondral allograft designed to augment marrow stimulation for articular cartilage repair. Geraghty, S., Kuang, JQ., Yoo, D., et al.[2018]

In a study of 19 patients with full-thickness cartilage defects in the knee, treatment with cryopreserved osteochondral allografts led to significant improvements in knee function and quality of life, as shown by increases in various clinical outcome scores over an average follow-up of 41.9 months.

Despite positive outcomes, the study reported a reoperation rate of 21.1%, indicating that while the treatment can be effective, there is a notable risk of complications, particularly in patients with more complex (bipolar) cartilage lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Outcomes of Cryopreserved Osteochondral Allograft for Patellofemoral Cartilage Defects at Minimum 2-Year Follow-up. Melugin, HP., Ridley, TJ., Bernard, CD., et al.[2022]

Fresh osteochondral allografts, harvested within 24 hours of donor death and preserved for up to 4 days, maintain 100% viability of cartilage and provide a strong structural support for knee defect repairs, making them suitable for younger, active patients.

Long-term survival rates for these allografts are promising, with 95% survival at 5 years, 71% at 10 years, and 66% at 20 years, although factors like patient age and specific conditions can negatively impact outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical experience with fresh osteochondral allografts for articular knee defects in high demand patients. Shasha, N., Aubin, PP., Cheah, HK., et al.[2022]

In a study involving 36 adult sheep, different cryopreservation methods for osteochondral allografts showed no significant differences in cartilage integration after 6 months, indicating that the methods tested may not be effective.

The results suggest that the cryopreservation protocols used in this study do not support successful integration of osteochondral allografts in clinical practice, leading to a recommendation against their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scanty integration of osteochondral allografts cryopreserved at low temperatures with dimethyl sulfoxide. Forriol, F., Longo, UG., Alvarez, E., et al.[2021]

Osteochondral allografts, especially fresh ones, have shown promising results in treating full-thickness cartilage defects in the knee, indicating their efficacy in clinical settings.

There is increasing interest in using cryopreserved grafts due to their potential for better tissue banking and the ability to overcome delays in obtaining fresh grafts, supported by encouraging laboratory data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteochondral allografts in the treatment of articular cartilage injuries of the knee. Hennig, A., Abate, J.[2018]

Fresh osteochondral allografts for treating larger lesions (>2.5-cm2) show good durability, with 88% of patients returning to sports and over 75% having a 10-year survival rate.

The effectiveness of these allografts is significantly affected by chondrocyte viability and density, which decline during preservation, leading to higher failure rates when the tissue is acellular.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: The Acellular Osteochondral Allograft, the Emperor Has New Clothes. Mandelbaum, BR., Chahla, J.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8808817/

Prospective Outcomes of Cryopreserved Osteochondral ... Patients with unipolar cartilage defects involving the patellofemoral compartment of the knee can have positive outcomes at minimum 2-year follow-up.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667254525000265

Cryopreserved osteochondral allografts: are they similar in ... 4, 5 Several studies have demonstrated promising results for fresh OCA transplantation in the knee with good-to-excellent outcomes reported in ...

3. trialx.com trialx.com/clinical-trials/listings/310714/evaluating-cryopreserved-osteochondral-allograft-cores-for-the-treatment-of-osteochondral-lesions-in-the-knee/

Evaluating Cryopreserved Osteochondral Allograft Cores ... The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of ...

4. withpower.com withpower.com/trial/phase-osteochondral-defect-2-2024-c4fe2

Osteochondral Allografts for Knee Defects Osteochondral allografts, especially fresh ones, have shown promising results in treating full-thickness cartilage defects in the knee.

5. allosource.org allosource.org/wp-content/uploads/2023/02/ProChondrix-CR-Early-Prospective-Outcomes-White-Paper-FINAL-1.pdf

PROCHONDRIX® CR: EARLY PROSPECTIVE CLINICAL ... Most notably at 36 months, IKDC scores improved by 86.3% and KOOS Quality of life scores improved by 132.5% from preoperative scores. There are many options for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6053312/

Implantation of a Novel Cryopreserved Viable Osteochondral ... Patients were followed up to 2 years after implantation of the CVOCA and all three patients had satisfactory outcomes without adverse events. Controlled ...

7. allosource.org allosource.org/prochondrix-cr-allosources-novel-laser-etched-cryopreserved-osteochondral-allograft-shows-positive-patient-reported-outcomes-in-prospective-clinical-study-on-focal-articular-cartilage-defects-in-t/

ProChondrix CR, AlloSource's Novel Laser Etched ... Most notably at 36 months, IKDC scores improved by 86.3% (Figure 1) and KOOS Quality of Life scores improved by 132.5% from the preoperative ...