Overview
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
Description
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled study in which the safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee OA. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
As this is a Pilot Study primarily designed to evaluate safety, no control will be used. The dosing groups will consist of either 2cc WJ Allograft (Low Dose), 3cc WJ Allograft (Medium Dose), or 4cc WJ Allograft (High Dose) with 120 total patients randomized into the three arms equally. In addition to baseline outcome instruments along with imaging and laboratory studies, patients will be followed for one year for evaluation of safety, pain relief and functional improvements.
Eligibility
Inclusion Criteria:
- Be over age 30
- Diagnosed with Grade II or III OA on the KL scale (in one knee).
- Body Mass Index (BMI) <50Kg/m2
- Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS)
- Female patients must be abstinent, surgically sterilized or postmenopausal
- Premenopausal females must have a negative pregnancy test, on contraceptive measures and do not anticipate pregnancy during the duration of the study.
- Be willing and capable of giving written informed consent to participate in English.
- Be willing and capable of complying with study-related requirements, procedures and visits in English.
Exclusion Criteria:
- Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
- Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team.
- Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months.
- Have had surgery on the index knee with the past 6 months.
- Had a traumatic injury to the index knee with the past 3 months.
- Planned elective surgery during the course of the study.
- A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
- Be on immunosuppressive medications.
- Have a diagnosis of carcinoma with the past 2 years.
- Have a knee infection or have used antibiotics for knee infection within the past 3 months.
- Have participated in any other clinical trial or treatment (not just for the knee, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
- Female patients who are breast feeding or are pregnant or desire to become pregnant during the course of the study.
- Contraindications to radiographic or MRI imaging.
- Serious neurological, psychological or psychiatric disorders.
- Injury or disability claims under current litigation or pending or approved workers compensation claims.
- Have a known drug allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin.