Status:
NOT_YET_RECRUITING
Evaluation of Safety and Efficacy of Wharton's Jelly Compared to Hyaluronic Acid and Saline for Knee Osteoarthritis.
Lead Sponsor:
BioIntegrate
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of intraarticular injection of umbilical cord derived Wharton's Jelly compared to hyaluronic acid and saline for treatment of knee ost...
Detailed Description
Osteoarthritis (OA) is the most common joint disorder in the United States (US), affecting approximately 12% (\~30 million) of US adults aged between 25 and 74 years. By 2030, the number of US adults ...
Eligibility Criteria
Inclusion
- Patients must be 18 years or older.
- Must have a body mass index (BMI) of \< 50Kg/m2.
- Must be able to comply with the requirements of study visits.
- Diagnosed with mild to moderate knee osteoarthritis (OA) in one knee only - Grade 2 or 3 on the Kellgren Lawrence (KL) grading scale.
- Pain score of 4 or more on the NPRS (on scale of 0 to 10).
- Female patients were abstinent, surgically sterilized or postmenopausal.
- Premenopausal females with negative pregnancy test, and who does not anticipate pregnancy and will actively practice an accepted contraceptive method for the duration of study.
- Males with premenopausal female partners, will take contraceptive measures for the duration of study.
- Be willing and capable of giving written informed consent to participate in this clinical study.
- Be willing and capable of complying with study-related requirements, procedures and visits.
Exclusion
- Patients who have taken any pain medications including NSAIDs within 2 weeks, prior to the study injection date, regularly use anticoagulants, substance abuse history, and/or failure to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to site principal investigator and study team.
- Patients who are positive on special tests and stability tests on the physical exam case report form.
- Patients with intraarticular injection of any drug including corticosteroids, viscosupplementation in the index knee in last 3 months.
- Patients with index knee surgery within last 6 months.
- Patients with traumatic injury to index knee within last 3 months.
- Patients with planned elective surgery during the course of the study.
- Patients with organ or hematologic transplantation history, rheumatoid arthritis or other autoimmune disorders.
- Patients on immunosuppressive medication/treatment, diagnosis of non-basal cell carcinoma within last 5 years.
- Patients with knee infection or who used antibiotics for knee infection within last 3 months.
- Patients who participated in another clinical trial or treatment with any investigational product within last 30 days prior to inclusion in the study.
- Female patients who are breast feeding or are pregnant or desire to be pregnant during the course of the study.
- Patients with contraindication to X-ray or MRI imaging.
- Patients with serious neurological, psychological or psychiatric disorders.
- Patients with other medical conditions determined by site principal investigator as interfering with the study.
- Patients with an injury or disability claim under current litigation or pending or approved workers' compensation claim.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04711304
Start Date
January 1 2023
End Date
June 1 2026
Last Update
July 21 2022
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