Laser Cell Therapy for Knee Cartilage Repair

Knee Osteoarthritis Clinical Trial

Official title:

Combined Effect of IPG Medical Charlie Laser and Bone Marrow Grafting on Cartilage Defects of the Knee

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04001361
• Other study ID #: LRK1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: Endocellutions
• Contact: Gennie Arbogast, DO
• Phone: 7402648000
• Email: garbogast[@]trinityhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Laser Cell Therapy
Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair

Locations

Country	Name	City	State
United States	Trinity Sports Medicine	Steubenville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Endocellutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI	Pre procedure MRI and post MRI is taken to measure disease modification	one year
Primary	VAS Score	Pre procedure and post procedure Pain score	one year
Primary	KOOS score	Pre procedure and post procedure Improvement in daily living and pain	one year
Primary	Treadmill Test	Pre procedure and post procedure, the patient will walk for 12 minutes with a gradual increase and a change in pain will be evaluated	one year
Primary	Swiss Ball wall squat test	Swiss Ball wall squat test to asses functional recovery.	one year