ProChondrix CR for Cartilage Damage

Not currently recruiting at 3 trial locations
CM
JB
BE
CM
EE
Overseen ByElizabeth Esterl, DNP, MS, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called ProChondrix CR, a cartilage repair product, to determine its effectiveness for knee pain caused by cartilage damage. The focus is on improving physical function and reducing knee pain, specifically targeting defects on the femoral condyle or patella. Individuals with moderate to severe knee pain, unresponsive to other treatments, might be suitable candidates. Participants should have a stable knee and be prepared for a procedure that combines marrow stimulation with ProChondrix CR. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from a potentially effective new therapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have received hyaluronic acid injections into the joint space within 90 days before surgery, you may not be eligible.

Is there any evidence suggesting that ProChondrix CR is likely to be safe for humans?

Research has shown that ProChondrix CR, a type of cartilage graft, is generally safe. It maintains a high number of living, healthy cells. Studies report that 94.97% of the cells in ProChondrix CR remain alive after two years of storage, indicating the treatment's stability over time.

Thorough testing of the donor tissue used for ProChondrix CR ensures safety and helps reduce the risk of negative reactions. Overall, evidence suggests that ProChondrix CR is well-tolerated, making it a promising option for treating cartilage problems.12345

Why do researchers think this study treatment might be promising?

ProChondrix CR is unique because it uses a fresh osteochondral allograft, which is a graft taken from donor cartilage tissue, to repair articular cartilage defects. Unlike traditional treatments like microfracture surgery or autologous chondrocyte implantation, which rely on stimulating the patient's own cartilage to heal, ProChondrix CR directly provides live, healthy cartilage cells and essential growth factors to the damaged area. Researchers are excited about this approach because it has the potential to improve cartilage repair by more closely mimicking the natural structure and function of healthy cartilage, potentially leading to better and faster recovery outcomes.

What evidence suggests that ProChondrix CR might be an effective treatment for symptomatic cartilage defects?

Studies have shown that ProChondrix CR can lead to positive outcomes for people with knee cartilage damage. Research indicates that this treatment can improve movement and reduce knee pain. In the short term, patients reported better results after using ProChondrix CR for issues in specific knee areas, such as the kneecap and the end of the thigh bone. A review of studies found that treatments like ProChondrix CR have a high success rate, with 86.7% still effective after five years. These findings suggest that ProChondrix CR may be an effective option for repairing knee cartilage damage.26789

Who Is on the Research Team?

JB

Jill Bagdasarian

Principal Investigator

AlloSource

BE

Beth Esterl

Principal Investigator

AlloSource

EE

Elizabeth Esterl, DNP, MS, RN

Principal Investigator

AlloSource

Are You a Good Fit for This Trial?

Inclusion Criteria

Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e. medication, bracing, physical therapy) and/or previous surgical intervention;
Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilage defect on the femoral condyle or patella between ≥ 1 cm2 and ≤ 5 cm2, measured as a rectangle length x width;
Will be having a marrow stimulation plus ProChondrix CR procedure;
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical intervention for cartilage defect repair using ProChondrix CR

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

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

What Are the Treatments Tested in This Trial?

Interventions

  • ProChondrix CR

Find a Clinic Near You

Who Is Running the Clinical Trial?

AlloSource

Lead Sponsor

Trials
10
Recruited
700+

Citations

PROCHONDRIX® CR: EARLY PROSPECTIVE CLINICAL ...In conclusion, PROCR demonstrated positive, short-term, prospective, clinically reported patient outcomes in focal cartilage lesions of the patella and femoral ...
Short term clinical outcomes of a Prochondrix® thin laser ...A meta-analysis of osteochondral allografting demonstrated a mean 86.7% survival rate at 5 years with significant improvements in clinical ...
Prospective Evaluation of ProChondrix CR for Repair ...The purpose of this clinical study is to evaluate the use of ProChondrix Cryopreserved Osteochondral Allograft to obtain evidence of effectiveness, defined as ...
ProChondrix-CR-Early-Prospective-Clinical-Outcomes-for- ...In conclusion, PROCR demonstrated positive, short-term, prospective, clinically reported patient outcomes in focal cartilage lesions of the patella and femoral ...
Research Shows ProChondrix® CR Maintains Consistent ...The data displays viable cells within each ProChondrix CR sample that has been cryopreserved for a period of two years.
ProChondrix® CRProChondrix CR is an off-the-shelf, cryopreserved osteochondral allograft used to treat surface cartilage lesions. 94.97% chondrocyte viability after two ...
ProChondrix CRProChondrix CR is a cryopreserved, fresh osteochondral allograft with live cells for articular cartilage repair, used in orthopedic procedures.
ProChondrix CRThe donor and the tissue used to produce ProChondrix CR are extensively tested to ensure that it is safe. ProChondrix CR. Actual Size. Enhanced to Show Texture.
Research Shows ProChondrix® CR Maintains Consistent ...The data displays viable cells within each ProChondrix CR sample that has been cryopreserved for a period of two years.
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