Is NCT06915233 recruiting in Durham, NC?

Yes, NCT06915233 is currently enrolling participants at its Durham, NC location. This chondral defect clinical trial is accepting qualified participants.

How do I join the chondral defect clinical trial in Durham?

To join this clinical trial in Durham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Durham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chondral Defect Clinical Trial in Durham, NC (Phase 3)

About This Chondral Defect Study in Durham

The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus.

Sponsor: Vericel Corporation

Who Can Participate

Inclusion Criteria

Age 17 to 65 at the time of planned randomization visit (Visit 2).

One or more symptomatic chondral or osteochondral lesion/s as defined by FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50.

International Cartilage Repair Society (ICRS) Score Grade 3 or 4 chondral or osteochondral lesion/s located on the talus with or without cysts, including shoulder lesions (lesions on the talar neck), and amenable to treatment with the surgical procedure specified at randomization.

At least 1 lesion ≥ 1.2 cm².

Written informed consent and assent (as applicable) per Institutional Review Board (IRB) requirements.

Participant will refrain from using Non-steroidal Anti-inflammatory Drugs (NSAIDS) for 12 weeks post-study treatment. (Post-surgical use of low-dose aspirin for clot prevention is acceptable).

Participant will restrict pain medication to over-the-counter analgesics (NSAIDs or acetaminophen/paracetamol) after 12 weeks post-study treatment.

Participant must have Hematocrit ≥30.0%; White Blood Cell count ≤14,000 cells/μL; Platelet Count ≥50,000 platelets/μL; Creatinine ≤2.0 mg/dL; and International Normalized Ratio (INR) ≤1.6.

Exclusion Criteria

Lesions with an underlying bony defect depth of \> 5 mm.

Any surgery on the target joint within 24 weeks prior to Visit 1 (not including diagnostic ankle arthroscopy).

Previous investigational drug, biologic or device use within 12 weeks prior to Visit.

Avascular necrosis of the target ankle.

Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target ankle joint.

Participant with "kissing lesions" (bipolar lesions, involving both the tibia and talus), or with bilateral lesions in both ankles.

Participant with lesions that require an osteotomy procedure to allow for MACI implantation as determined at the time of ankle arthroscopy (Visit 2).

Concomitant systemic inflammatory diseases or other conditions that affect the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis).

History of advanced or severe osteoarthritis of the ankle as determined by prior surgical history confirming no joint space (i.e., "bone on bone") or radiographic evidence of Modified Kellgren-Lawrence Grade 4 arthritis (i.e., osteophytes on lateral and medial malleoli and at the tibiotalar joint margins, narrowing of the joint space width \> 50%, and tibiotalar sclerosis), Van Dijk Grade III (i.e., total or subtotal destruction of the joint space) or the equivalent.

Known history of septic arthritis in the target ankle joint within 1 year prior to Visit 1.

Current malignancy or treatment for malignancy within the past 5 years prior to Visit 1, excluding non-melanoma skin cancer.

Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.

Females who are pregnant or lactating.

Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems included but are not limited to:

Any condition that has potential for negatively impacting intra- or postoperative course (e.g., uncontrolled diabetes, heavy smoking). - Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8.0% and/or fasting plasma glucose \>250 mg/dL (13.9 mmol/L) within the last 90 days prior to Screening Visit 1 - Heavy smoking is defined as current smoker with use of ≥20 cigarettes per day (≥1 pack/day) at the time of Screening Visit 1.

Conditions that limit compliance with rehabilitation program.

Any condition that has potential for significantly limiting participant's ability to assess postoperative ankle function.

Any condition, psychiatric or otherwise, that would preclude informed consent/assent, consistent follow-up, or compliance with any aspect of the clinical trial.

Participant is currently abusing drugs or alcohol or, in the opinion of the Investigator, at high risk for poor compliance.

Any abnormal screening blood work that the Investigator deems clinically significant in addition to the parameters delineated in Inclusion Criterion #8.

Injection of hyaluronic acid (HA), platelet-rich plasma (PRP), and/or corticosteroids in the target ankle within 90 days prior to Visit 1.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT06915233) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chondral Defect Treatment Options in Durham, NC

If you're searching for chondral defect treatment options in Durham, NC, this clinical trial (NCT06915233) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced chondral defect specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chondral defect clinical trials near you to find additional studies recruiting in your area.

Chondral Defect Clinical Trial in Durham, NC

Expert Care in Durham

IRB Approved

No-Cost Care

Apply for This Durham Location

Why Participate?

Simple Process