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Tests treatment safety and results for Osteoarthritis
Official title Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT02844751
What this study is testing
What is [StroMed + platelet rich plasma (PRP)]?
[StroMed + platelet rich plasma (PRP)] is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90. Healthy volunteers may be eligible.
You may be able to join if
- Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration or chronic injury.
- Patients range from 18-90 years of age.
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
- Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
- Patients with adequate cardiac and respiratory function.
You likely can't join if
- Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
- Diagnosis of a transient ischemic attack in the 6 months prior to screening.
- Patients infected with hepatitis B, C or HIV.
- Patients with Body Mass Index (BMI) \> 40kg/m2
- Presence of active infection.
See the full eligibility criteria
- Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration or chronic injury.
- Patients range from 18-90 years of age.
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
- Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
- Patients with adequate cardiac and respiratory function.
- Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT
- Patients must have adequate immune system function, with no known immunodeficiency disease.
- Greater than 6 months knee pain on the index side (left or right knee).
- Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
- Diagnosis of a transient ischemic attack in the 6 months prior to screening.
- Patients infected with hepatitis B, C or HIV.
- Patients with Body Mass Index (BMI) \> 40kg/m2
- Presence of active infection.
- Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
- Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:
- Knee instability.
- A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery.
- Gout or pseudo gout
- Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis
- Corticosteroid injection at treatment site within 1 month
- Consistent use of NSAIDs within 48 hours of procedure.
The study team makes the final eligibility decision.
Where it's taking place
- Grove City, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grove City, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.