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Cell Therapy
Platelet Rich Plasma for Platelet Rich Plasma
N/A
Waitlist Available
Led By Michael Baria, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months, 6 months, and 12 months
Awards & highlights
Study Summary
This trial will compare the clinical outcomes of two different interventions for treating knee osteoarthritis: PRP (standard intervention) and Microfragmented adipose tissue (investigational). The hypothesis is that both interventions will result in significant improvement in patient-reported outcomes, but that Microfragmented adipose tissue will provide superior outcomes.
Eligible Conditions
- Platelet Rich Plasma
- Osteoarthritis
- Microfragmented Adipose Tissue
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 months, 6 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, 6 months, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
KOOS Pain [Knee Injury and Osteoarthritis Outcome Score]
Secondary outcome measures
Tegner Activity Scale
VAS [Visual Analog Pain Scale] Pain Score
Trial Design
2Treatment groups
Active Control
Group I: Platelet Rich PlasmaActive Control1 Intervention
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Group II: Microfragmented adipose tissueActive Control1 Intervention
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
828 Previous Clinical Trials
505,672 Total Patients Enrolled
Michael Baria, MDPrincipal Investigator - Ohio State University
OSU Harding Hospital, Ohio State University Hospital - Wexner Medical Center, Richard M. Ross Heart Hospital
Wright State University School Of Medicine (Medical School)
1 Previous Clinical Trials
14 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process of this clinical trial still open?
"Based on clinicaltrials.gov, this research endeavour is no longer recruiting participants; it was first posted 3rd March 2020 and updated 8th April 2022. Despite that, there remain 693 other medical trials open for patient recruitment at present."
Answered by AI
Who would be most suited to join this scientific exploration?
"Qualified candidates for this trial should possess tissue adhesives and fall between the ages of 25 to 75. Currently, 79 participants are needed for this research project."
Answered by AI
Does this study permit participation of individuals under the age of 65?
"This trial is exclusive to adults between the ages of 25 and 75 years old. Those under 18 or above 65 can instead participate in 38 trials designed for them specifically, or 657 studies that are open to all age groups."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Pennsylvania
Ohio
Other
How old are they?
65+
18 - 65
What site did they apply to?
The Ohio State University Sports Medicine Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
Stiffness and pain in knees. I am considering any and all treatment modalities other than surgery.
PatientReceived no prior treatments
I am looking for alternatives to future knee replacements. I have had partial medial meniscectomies in both knees. I take nSaids daily to relieve pain, and would like to reduce their use.
PatientReceived 2+ prior treatments
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