Cartilage DegenerationNCT03648463
Use of MRI Labeling Technique to Track Mesenchymal Stem Cell Survival in Orthopaedic Conditions
A study testing arthroscopy of the affected knee/ Bone Marrow Concentrate Injection in people with Cartilage Degeneration and Rotator Cuff Tear, run by Stanford University.
Trial summary
The primary objective is to determine whether a surgical intervention involving removing of the calcified cartilage cap in patients with Grade II Kellgren-Lawrence osteoarthritis influences the incorporation of labeled bone marrow aspirate concentrate (BMAC)-derived cells within the cartilage regenerate vs labeled… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Cartilage Degeneration, Rotator Cuff Tear, Osteoarthritis, Knee
- What is being tested?
- arthroscopy of the affected knee/ Bone Marrow Concentrate Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 30-70 patients with Kellgren grade II-III osteoarthritis,
- Symptomatic knee pain greater than 6 months
- At least one discrete contained chondral defect
- Failed a minimum of 6 weeks of physical therapy
- Grossly normal knee alignment: <5 degrees of varus or valgus alignment
- Lesion located on medial or lateral femoral condyle or trochlea
Who cannot join
- Radiographs demonstrating either no or little osteoarthritis (Kellgren-Lawrence Grade 0 or 1)
- Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis
- Malalignment of mechanical axis > or = 5 degrees of varus/valgus
- Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
- Ligamentous knee instability
- The subject is on ongoing specific osteoarthritis drugs such as chondroitin sulphate, diacerein, N-glucosamine, piascledine, capsaicin in the 2 weeks prior to baseline treatment
- BMI > 30
- Currently pregnant or planning to become pregnant (no MRI possible).
About this study
Official title: Effect of Surgical Intervention on Mesenchymal Stem Cell Survival in Soft Tissue Reconstructive Procedures Using a Novel MRI Labeling Technique
The primary objective is to determine whether a surgical intervention involving removing of the calcified cartilage cap in patients with Grade II Kellgren-Lawrence osteoarthritis influences the incorporation of labeled bone marrow aspirate concentrate (BMAC)-derived cells within the cartilage regenerate vs labeled BMAC cells delivered after arthroscopy without removing of the calcified cartilaginous layer. The survival and incorporation of the BMAC labeled cells will be evaluated with MRI using the Ferumoxytol infusion stem cell labeling technique. The second arm of the study evaluating cell fate after injecting stem cells under a rotator cuff repair will also be explored.
The secondary objectives are to 1) determine which surgical intervention leads to better clinical outcomes as measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months, and 2) determine who long we can track the labeled-BMAC cells in the knee.
Read the detailed description
Articular cartilage repair and regeneration has become a focal point for scientists and surgeons in search for a biological treatment for osteoarthritis that has failed non-operative management. Surgeons have begun to harvest and centrifuged bone marrow aspirate to produce bone marrow aspirate concentrate (BMAC) in hopes that the mesenchymal stem cells in the bone marrow aspirate can stimulate cartilage regeneration in areas of articular cartilage deficiency. This study is a first-in-human blinded randomized clinical trial using labeled BMAC cells in adults diagnosed with grade II-III Kellgren-Lawrence osteoarthritis.
This is a single site study where 20 cases among eligible patients will be identified and randomly assigned to either the control (no calcified cartilage) or experimental (calcified cartilage removed) group. A power analysis will be performed after 20 patients to determine the total number of patients required to reach adequate power.
A patient will receive an infusion of Feraheme 2 days before the procedure and a baseline MR Pelvis and knee. A nurse will be present at all times during the infusion to monitor vitals. On the day of the procedure patient will undergo harvesting of the bone marrow from the pelvis and arthroscopy procedure involving menisectomy, synovectomy and debridement. Patients in the experimental group will also undergo removal of the calcified cartilage cap. The bone marrow aspirate will be centrifuged and about 5-7 cc of BMAC injected into knee. MRIs will be done at the 2 day mark for confirmation of the labeling of the mesenchymal cells, and at the two week and 3 month mark. Patient related Outcomes will be measured using the Knee injury and Osteoarthritis Score at 12 months follow up.
- Being tested
- arthroscopy of the affected knee/ Bone Marrow Concentrate Injection
- Medical subject headings
- Rotator Cuff Injuries, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopy of the affected knee/ Bone Marrow Concentrate InjectionProcedure or surgery
Also called Injection of bone marrow aspirate concentrate harvested from the patient's iliac crest (produced using the Harvest/Terumo BCT system)
Subjects will undergo knee arthroscopy for debridement, menisectomy and synovectomy of the cartilage defects. Subjects will also be injected with bone marrow aspirate concentrated harvested from the pelvis and centrifuged (produced produced using the Harvest/Terumo BCT system)
| Study group | Role | What they receive |
|---|---|---|
| arthroscopy with removal of calcified cartilage | Experimental | This arm will have patients who will get surgical intervention (menisectomy, synovectomy and debridement) along with removal of the calcified cartilage layer. The patients will also get 5 cc of BMAC produced from The Harvest/Terumo BCT system. Receives: Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate Injection |
| arthroscopy without removal of calcified cartilage | Active comparator | This arm will have patients who will get surgical intervention (menisectomy, synovectomy and debridement) but with retention of the calcified cartilage cap. The patients will also get 5 cc of BMAC produced from The Harvest/Terumo BCT system. Receives: Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integration of the mesenchymal stem cells.
Number of integrated labeled mesenchymal stem cells in the cartilage regenerate counted from from MRI imaging.
Measured: 3 months
Secondary outcomes (1)
Knee Injury and Osteoarthritis Outcome Score (pain subscale)
KOOS pain score at baseline and at 12 months to measure functional outcomes. This sub scale of the KOOS questionnaire has a possible total of 100 points (higher scores mean less pain)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Oct 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DegenerationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Enweze, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648463
- Sponsor's protocol ID
- IRB-46711
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2018
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surgical Intervention on Mesenchymal Stem Cell Survival in Soft Tissue Reconstructive Procedures Using a Novel MRI Labeling Technique
- ClinicalTrials.gov ID
- NCT03648463
- Acronym / sponsor ID
- IRB-46711
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Aug 2018 (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.
The primary objective is to determine whether a surgical intervention involving removing of the calcified cartilage cap in patients with Grade II Kellgren-Lawrence osteoarthritis influences the incorporation of labeled bone marrow aspirate concentrate (BMAC)-derived cells within the cartilage regenerate vs labeled BMAC cells delivered after arthroscopy without removing of the calcified cartilaginous layer. The survival and incorporation of the BMAC labeled cells will be evaluated with MRI using the Ferumoxytol infusion stem cell labeling technique. The second arm of the study evaluating cell fate after injecting stem cells under a rotator cuff repair will also be explored.
The secondary objectives are to 1) determine which surgical intervention leads to better clinical outcomes as measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months, and 2) determine who long we can track the labeled-BMAC cells in the knee.
Detailed description
Articular cartilage repair and regeneration has become a focal point for scientists and surgeons in search for a biological treatment for osteoarthritis that has failed non-operative management. Surgeons have begun to harvest and centrifuged bone marrow aspirate to produce bone marrow aspirate concentrate (BMAC) in hopes that the mesenchymal stem cells in the bone marrow aspirate can stimulate cartilage regeneration in areas of articular cartilage deficiency. This study is a first-in-human blinded randomized clinical trial using labeled BMAC cells in adults diagnosed with grade II-III Kellgren-Lawrence osteoarthritis.
This is a single site study where 20 cases among eligible patients will be identified and randomly assigned to either the control (no calcified cartilage) or experimental (calcified cartilage removed) group. A power analysis will be performed after 20 patients to determine the total number of patients required to reach adequate power.
A patient will receive an infusion of Feraheme 2 days before the procedure and a baseline MR Pelvis and knee. A nurse will be present at all times during the infusion to monitor vitals. On the day of the procedure patient will undergo harvesting of the bone marrow from the pelvis and arthroscopy procedure involving menisectomy, synovectomy and debridement. Patients in the experimental group will also undergo removal of the calcified cartilage cap. The bone marrow aspirate will be centrifuged and about 5-7 cc of BMAC injected into knee. MRIs will be done at the 2 day mark for confirmation of the labeling of the mesenchymal cells, and at the two week and 3 month mark. Patient related Outcomes will be measured using the Knee injury and Osteoarthritis Score at 12 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arthroscopy with removal of calcified cartilage | Experimental | Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate InjectionThis arm will have patients who will get surgical intervention (menisectomy, synovectomy and debridement) along with removal of the calcified cartilage layer. The patients will also get 5 cc of BMAC produced from The Harvest/Terumo BCT system. |
| arthroscopy without removal of calcified cartilage | Active comparator | Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate InjectionThis arm will have patients who will get surgical intervention (menisectomy, synovectomy and debridement) but with retention of the calcified cartilage cap. The patients will also get 5 cc of BMAC produced from The Harvest/Terumo BCT system. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 30-70 patients with Kellgren grade II-III osteoarthritis,
- Symptomatic knee pain greater than 6 months
- At least one discrete contained chondral defect
- Failed a minimum of 6 weeks of physical therapy
- Grossly normal knee alignment: <5 degrees of varus or valgus alignment
Key exclusion criteria (8 listed)
- Radiographs demonstrating either no or little osteoarthritis (Kellgren-Lawrence Grade 0 or 1)
- Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis
- Malalignment of mechanical axis > or = 5 degrees of varus/valgus
- Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
- Ligamentous knee instability
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 |
|---|---|---|
| arthroscopy of the affected knee/ Bone Marrow Concentrate InjectionAlso: Injection of bone marrow aspirate concentrate harvested from the patient's iliac crest (produced using the Harvest/Terumo BCT system)Subjects will undergo knee arthroscopy for debridement, menisectomy and synovectomy of the cartilage defects. Subjects will also be injected with bone marrow aspirate concentrated harvested from the pelvis and centrifuged (produced produced using the Harvest/Terumo BCT system) | Procedure or surgery | arthroscopy with removal of calcified cartilage, arthroscopy without removal of calcified cartilage |
Primary outcome
Integration of the mesenchymal stem cells.
Time frame: 3 months
Number of integrated labeled mesenchymal stem cells in the cartilage regenerate counted from from MRI imaging.
1 secondary outcome
Knee Injury and Osteoarthritis Outcome Score (pain subscale)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Lawrence Enweze, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopy of the affected knee/ Bone Marrow Concentrate Injection in people with Cartilage Degeneration and Rotator Cuff Tear, run by Stanford University.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integration of the mesenchymal stem cells. (time frame: 3 months). 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 29 Aug 2022.