Alternative Methods for Defining Osteoarthritis and the Impact on Estimating Prevalence in a US Population-Based Survey.
Miriam G Cisternas, Louise Murphy, Jeffrey J Sacks...
https://pubmed.ncbi.nlm.nih.gov/26315529Actively Recruiting
Early Phase 1
Age: 30Years +
All Genders
ID06608134
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
Led by R3 Medical Research · Updated on 2024-09-23
120
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of injecting Wharton's Jelly (WJ) allograft directly into the knee joint of patients with knee osteoarthritis (OA). This pilot study is randomized, prospective, and open-label, focusing on dose escalation without a control group. It includes patients aged 30 and older with moderate knee OA. The study aims to observe safety and possible improvements in pain and function over one year. Participants will be randomly assigned to receive one of three doses of WJ allograft in a single knee injection: 2cc (low dose), 3cc (medium dose), or 4cc (high dose). A total of 120 patients will be evenly divided among these three groups. No placebo or control group is included since the primary goal is to assess safety. The treatment is administered as a direct injection into the affected knee joint. Throughout the study, participants will undergo various assessments including blood tests measuring inflammation and organ function at baseline, 1 week, 6 weeks, 3 months, 6 months, and 1 year after treatment. They will also complete pain and functional questionnaires at regular intervals to track changes. The study includes imaging and laboratory evaluations to monitor safety, pain relief, and functional improvements during the one-year follow-up period.
CONDITIONS
Brief Title
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
Who Can Participate
Age: 30Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Be over age 30
- Diagnosed with Grade II or III osteoarthritis on the KL scale in one knee
- Body Mass Index (BMI) less than 50 kg/m2
- Pain score of 4 or more on the Numeric Pain Rating Scale
- Female patients must be abstinent, surgically sterilized, or postmenopausal
- Premenopausal females must have a negative pregnancy test, use contraception, and not plan pregnancy during the study
- Able and willing to provide written informed consent in English
- Able and willing to comply with study procedures and visits in English
You will not qualify if you...
- Taken any pain medication including NSAIDs within 2 weeks before study injection
- Use anticoagulants or have substance abuse history without agreement to avoid knee-symptom modifying drugs during the study
- Had intra-articular knee injection or surgery in the index knee within past 6 months
- Had traumatic injury to the index knee within past 3 months
- Planned elective surgery during the study course
- History of organ or hematologic transplantation, rheumatoid arthritis, or autoimmune disorders
- Taking immunosuppressive medications
- Diagnosed with carcinoma within past 2 years
- Knee infection or antibiotic use for knee infection within past 3 months
- Participated in other clinical trials or treatments with investigational products within past 30 days
- Female patients who are breastfeeding, pregnant, or plan pregnancy during the study
- Contraindications to radiographic or MRI imaging
- Serious neurological, psychological, or psychiatric disorders
- Injury or disability claims under litigation or workers compensation
- Known allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - One-time injection with follow-up assessments over one year
Participants receive one intra-articular knee injection of Umbilical Cord Wharton's Jelly Allograft at low, medium, or high dose to evaluate safety and feasibility for knee osteoarthritis.
1 treatment visit and multiple follow-up visits over 1 year
Follow-up
Duration - Up to 1 year after injection
Participants are monitored for safety, pain relief, and functional improvements with scheduled assessments including laboratory tests and outcome surveys.
Visits at 24 hours, 1 week, 6 weeks, 3 months, 6 months, and 1 year post-injection
Trial Site Locations
Total: 5 locations
1
R3 Anti Aging Scottsdale
Scottsdale, Arizona, United States, 85262
Actively Recruiting
2
R3 Anti Aging Beverly Hills
Beverly Hills, California, United States, 90210
Actively Recruiting
3
Optimal Medical Group
Fresno, California, United States, 93722
Actively Recruiting
4
Scheer Medical Wellness
New York, New York, United States, 10036
Actively Recruiting
5
Dr. Duc (Steve) Le, MD
Cleveland, Texas, United States, 77327
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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