Knee OsteoarthritisNCT04001361
Laser Cell Therapy for Knee Cartilage Repair
A study testing Laser Cell Therapy in people with Knee Osteoarthritis, run by Endocellutions at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Laser Cell Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Trinity Sports Medicine
Steubenville, Ohio, 43952
Gennie Arbogast, garbogast@trinityhealth.org
About this study
Official title: Combined Effect of IPG Medical Charlie Laser and Bone Marrow Grafting on Cartilage Defects of the Knee
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Laser Cell Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Cell TherapyProcedure or surgery
Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on. Receives: Procedure: Laser Cell Therapy |
| Laser Only | Experimental | 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. Receives: Procedure: Laser Cell Therapy |
| Laser plus Marrow | Experimental | 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. Receives: Procedure: Laser Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI
Pre procedure MRI and post MRI is taken to measure disease modification
Measured: one year
VAS Score
Pre procedure and post procedure Pain score
Measured: one year
KOOS score
Pre procedure and post procedure Improvement in daily living and pain
Measured: one year
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
Measured: one year
Swiss Ball wall squat test
Swiss Ball wall squat test to asses functional recovery.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start15 Jul 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endocellutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Scarpone, Principal investigator, Trinity Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001361
- Sponsor's protocol ID
- LRK1
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared unless the principal investigator decides to make public either through podium presentations or written publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of IPG Medical Charlie Laser and Bone Marrow Grafting on Cartilage Defects of the Knee
- ClinicalTrials.gov ID
- NCT04001361
- Acronym / sponsor ID
- LRK1
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- EndocellutionsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Procedure: Laser Cell TherapyUnder conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on. |
| Laser Only | Experimental | Procedure: Laser Cell TherapyUnder 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. |
| Laser plus Marrow | Experimental | Procedure: Laser Cell TherapyUnder 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Cell TherapyBone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair | Procedure or surgery | Laser Only, Laser plus Marrow, Sham |
Primary outcome
MRI
Time frame: one year
Pre procedure MRI and post MRI is taken to measure disease modification
VAS Score
Time frame: one year
Pre procedure and post procedure Pain score
KOOS score
Time frame: one year
Pre procedure and post procedure Improvement in daily living and pain
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
Swiss Ball wall squat test
Time frame: one year
Swiss Ball wall squat test to asses functional recovery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Individual participant dataSharing planned: No. Data will not be shared unless the principal investigator decides to make public either through podium presentations or written publication.
Related trials for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Scarpone principal investigator
Trinity Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Cell Therapy in people with Knee Osteoarthritis, run by Endocellutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gennie Arbogast, DO (7402648000, garbogast@trinityhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.