Laser Cell Therapy for Knee Cartilage Repair

Endocellutions

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Procedure: Laser Cell Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04001361

LRK1

Details and patient eligibility

About

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.

Full description

The creation of micro-channels into damaged knee cartilage will facilitate the movement of fluid into and out of the tissue to allow for more efficient nutrient diffusion. The addition of bone marrow aspirate will provide additional growth factor enriched nutrition to the tissue. The goal of this combination therapy is to facilitates the body's own reparative processes leading to improved patient well being.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Sham

Sham Comparator group

Description:

Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on.

Treatment:

Procedure: Laser Cell Therapy

Laser Only

Experimental group

Description:

Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser fiber is inserted into knee over an 18 gauge needle and micro-channels are made into the damaged cartilage.

Treatment:

Procedure: Laser Cell Therapy

Laser plus Marrow

Experimental group

Description:

Under conscience sedation, a 10mL marrow aspiration is performed. Laser fiber is inserted into the knee over an 18 gauge needle and micro-channels are made into the damaged cartilage. After the channels are made, marrow aspirate is injected over the same 18 gauge needle.

Treatment:

Procedure: Laser Cell Therapy