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Laser Cell Therapy for Knee Cartilage Repair

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Cell Therapy
Sponsored by
Endocellutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Trinity Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Sham

Laser Only

Laser plus Marrow

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

MRI
Pre procedure MRI and post MRI is taken to measure disease modification
VAS Score
Pre procedure and post procedure Pain score
KOOS score
Pre procedure and post procedure Improvement in daily living and pain
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
Swiss Ball wall squat test
Swiss Ball wall squat test to asses functional recovery.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2019
Last Updated
June 26, 2019
Sponsor
Endocellutions
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1. Study Identification

Unique Protocol Identification Number
NCT04001361
Brief Title
Laser Cell Therapy for Knee Cartilage Repair
Official Title
Combined Effect of IPG Medical Charlie Laser and Bone Marrow Grafting on Cartilage Defects of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endocellutions

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on.
Arm Title
Laser Only
Arm Type
Experimental
Arm 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.
Arm Title
Laser plus Marrow
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Laser Cell Therapy
Intervention Description
Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair
Primary Outcome Measure Information:
Title
MRI
Description
Pre procedure MRI and post MRI is taken to measure disease modification
Time Frame
one year
Title
VAS Score
Description
Pre procedure and post procedure Pain score
Time Frame
one year
Title
KOOS score
Description
Pre procedure and post procedure Improvement in daily living and pain
Time Frame
one year
Title
Treadmill Test
Description
Pre procedure and post procedure, the patient will walk for 12 minutes with a gradual increase and a change in pain will be evaluated
Time Frame
one year
Title
Swiss Ball wall squat test
Description
Swiss Ball wall squat test to asses functional recovery.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gennie Arbogast, DO
Phone
7402648000
Email
garbogast@trinityhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Scarpone
Organizational Affiliation
Trinity Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trinity Sports Medicine
City
Steubenville
State/Province
Ohio
ZIP/Postal Code
43952
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gennie Arbogast
Email
garbogast@trinityhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared unless the principal investigator decides to make public either through podium presentations or written publication.

Learn more about this trial

Laser Cell Therapy for Knee Cartilage Repair

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