Laser Cell Therapy for Knee Cartilage Repair
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Knee Osteoarthritis
In brief
Laser pulsed energy will be delivered over an optical fiber to create channels into damaged cartilage of the knee or knees. The channels have a diameter of approximately 100 microns or less and an approximate depth of 1 millimeter or less. Bone marrow aspirate will then be delivered into the damaged joint.
Key facts
- Study ID
- NCT04001361
- Run by
- Endocellutions
- People needed
- 45
- Starts
- 2019-07-15
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2019-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Kellergren grading scale of 2 or 3 in at least one compartment of either or both knees with no compartment representing a stage 4 in either knee.
- No significant MCL or LCL tear or laxity
- No significant meniscal tear. ( i.e. bucket handle)
You may not qualify if…
- Injection with the past 6 weeks
- Stage 4 osteoarthritis in either knee
- Uncontrolled Diabetes or any other metabolic syndrome
- BMI greater than 28
- Significant lower extremity deformity
- Bilateral or tri compartmental Knee OA
- Adults unable to consent
- Individuals who are not yet adults (infants, children, and teenagers, age < 18)
- pregnant women
- Prisoners
- Stage 4 osteoarthritis in either knee
- Subjects, who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Where it is running
- Trinity Sports Medicine — Steubenville, Ohio, United States
Full record on ClinicalTrials.gov
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