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Laser Cell Therapy for Knee Cartilage Repair

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ClinicalTrials.gov Identifier: NCT04001361
Recruitment Status : Not yet recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Endocellutions

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Laser Cell Therapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Sham laser means laser not turned on. Sham marrow means incision in skin made but no marrow drawn. Patient under conscience sedation. MRI and outcomes measures independently measured.
Primary Purpose: Treatment
Official Title: Combined Effect of IPG Medical Charlie Laser and Bone Marrow Grafting on Cartilage Defects of the Knee
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham
Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on.
Procedure: Laser Cell Therapy
Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair

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

Experimental: Laser plus Marrow
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.
Procedure: Laser Cell Therapy
Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair




Primary Outcome Measures :
  1. MRI [ Time Frame: one year ]
    Pre procedure MRI and post MRI is taken to measure disease modification

  2. VAS Score [ Time Frame: one year ]
    Pre procedure and post procedure Pain score

  3. KOOS score [ Time Frame: one year ]
    Pre procedure and post procedure Improvement in daily living and pain

  4. Treadmill Test [ Time Frame: one year ]
    Pre procedure and post procedure, the patient will walk for 12 minutes with a gradual increase and a change in pain will be evaluated

  5. Swiss Ball wall squat test [ Time Frame: one year ]
    Swiss Ball wall squat test to asses functional recovery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001361


Contacts
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Contact: Gennie Arbogast, DO 7402648000 garbogast@trinityhealth.org

Locations
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United States, Ohio
Trinity Sports Medicine Not yet recruiting
Steubenville, Ohio, United States, 43952
Contact: Gennie Arbogast       garbogast@trinityhealth.org   
Sponsors and Collaborators
Endocellutions
Investigators
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Principal Investigator: Michael Scarpone Trinity Sports Medicine

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Responsible Party: Endocellutions
ClinicalTrials.gov Identifier: NCT04001361     History of Changes
Other Study ID Numbers: LRK1
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared unless the principal investigator decides to make public either through podium presentations or written publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases