Shoulder ArthritisStemshoulderNCT04308213
Study on Shoulder Arthritis Treatment With Intra-articular Injections of Autologous Bone Marrow Aspirate.
A study testing Marrow Cellution System in people with Shoulder Arthritis, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Treatment of isolated osteoarthritis of the glenohumeral joint at the initial stages involves the use of numerous conservative or arthroscopic treatments with uncertain results and, upon their failure, the current solution for the resolution of symptoms is shoulder arthroplasty, an effective procedure but with… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Shoulder Arthritis
- What is being tested?
- Marrow Cellution System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2019to 30 Sep 2024
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged between 35 and 75.
- Light or moderate glenohumeral arthritis assessed by MRI.
- Failure after at least 6 months of conservative treatment (patients not responding to drug therapy with NSAIDs and pain killers, no benefit from hydro-kinesitherapy or physiotherapy, no benefit after a course of hyaluronic acid or PRP infiltrations, or after at least one corticosteroid infiltration)
- Ability and consent of patients to participate actively in the rehabilitation and clinical and radiological follow-up protocol;
- The signing of informed consent.
Who cannot join
- Patients incapable of understanding and will
- Patients with shoulder trauma within 6 months prior to surgery
- Patients with malignancies;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with metabolic thyroid disorders;
Show all 11Show fewer
- Patients abusing alcoholic beverages, drugs or drugs;
- Patients with signs of rotator cuff or long head biceps disease at MRI
- Patients with a history of untreated shoulder instability.
- Patients with arthroscopic evidence of rotator cuff injuries.
- Glenohumeral arthrosis "bone to bone".
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, Milano, 20089
Alessandro Castagna, MD, +390282244663, alessandro.castagna@humanitas.it
About this study
Official title: Interventional Study on the Treatment of Shoulder Osteoarthritis With Intra-articular Injections of Autologous Bone Marrow Aspirate.
Treatment of isolated osteoarthritis of the glenohumeral joint at the initial stages involves the use of numerous conservative or arthroscopic treatments with uncertain results and, upon their failure, the current solution for the resolution of symptoms is shoulder arthroplasty, an effective procedure but with significant costs and rates of morbidity, especially in young patients. Since the use of intra-articular injections of mesenchymal cells obtained from the bone marrow has proved effective in the treatment of gonarthrosis, our goal is to evaluate the effectiveness of the same therapy in the treatment of glenohumeral arthritis isolated.
Read the detailed description
Glenohumeral arthritis is one of the main reasons for persistent shoulder pain and reduced movement (range of motion, ROM) as it can compromise the work activity and also the normal daily activities, leading to the development of depressive syndromes. The final treatment is shoulder arthroplasty, which is effective but is associated with significant costs and morbidity rates. In addition, arthro-prosthesis is avoided in young patients due to longevity concerns and is not indicated in the early stages of arthritis. Currently, conservative treatments for patients with mild or moderate glenohumeral arthritis include non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, with low efficacy and a significant adverse effect profile, hyaluronic acid infiltrations, with good efficacy in initial treatment, and infiltrations of platelet-Rich Plasma (PRP), which have shown beneficial effects in knee arthritis. However, evidence for the glenohumeral joint are limited. In cases not responsive to conservative therapy, and especially in young patients, a valid alternative to the prosthesis is the arthroscopic treatment, with good results in the short term, but with relatively high failure rates that increase over time. Other types of nonprosthetic surgical treatment for chondral-humeral defects have low scientific evidence, with variable and uncertain results. In recent years, mesenchymal stem cells (MSC), derived from bone marrow or adipose tissue, due to the ability to differentiate into chondrogenic line cells, have emerged as cells with great therapeutic potential in patients with degenerative joint disorders. Since the knee joint is the most susceptible to pathology because of its mechanical load, most studies based on stem cell therapy regard the knee joint, reporting promising results in treatment in the treatment of early stages of arthritis. As regards the glenohumeral joint, since the most frequent pathology affects the tendons of the rotator cuff, almost all studies investigate the effect of MSC in the treatment of rotator cuff disorders with or without associated surgical repair techniques. Only a prospective study analyzed the effect of intra-articular MSC injection derived from bone marrow in 34 patients with isolated glenohumeral arthritis, reporting a significant decrease in pain and an improvement in shoulder function measured by the Disabilities of the Arm, Shoulder and Hand (DASH) scale at about 1 year, although study quality is very low. Since the use of intra-articular injections of mesenchymal cells obtained from the bone marrow has proved effective in the treatment of gonarthrosis, our study proposes to evaluate the long-term efficacy of this type of therapy in the treatment of the isolated glenohumeral arthritis.
- Conditions
- Shoulder Arthritis
- Being tested
- Marrow Cellution System
- Keywords
- arthritis, mesenchymal stem cells
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marrow Cellution SystemDevice
The treatment will be carried out in the operating room under ordinary hospitalization and provides the intra-articular application of 9 ml of autologous bone marrow aspirate in the glenohumeral joint affected by arthrosis. To obtain the necessary amount, a bone marrow aspirate of about 12 ml will be taken from the iliac crest by means of the Marrow Cellution System, Geistlich Italia. This autologous bone marrow aspirate will be injected using the same syringe into the glenohumeral joint affected by arthrosis under amplioscopic control.
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow aspirate | Experimental | All the patients enrolled in the study will be treated with the bone marrow aspirate obtained with the Bone Marrow Cellution Kit. Receives: Device: Marrow Cellution System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Constant-Murley score
Constant-Murley score: is a scale of 100 points that defines the level of pain and the ability to perform normal daily activities of the patient. The test is divided into 4 subscales: pain (15 points), daily life activity (20 points), force (25 points), range of movement: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
Measured: Timepoints: Screening, 3, 6, 12, 24, 36, and 48 months
Change of the VAS pain score
Visual analogue Scale (VAS): The patient is asked to quantify pain by indicating its intensity on an visual analog scale (0 no pain, 10 the worst pain).
Measured: Timepoints: Screening, 3, 6, 12, 24, 36, and 48 months
Secondary outcomes (5)
Change of range of motion (ROM)
Range of motion (ROM): the range of motion will be evaluated during the clinical examination using a goniometer in terms of anterior flexion, abduction, external rotation with elbow to side (ER1), external rotation with elbow abducted to 90° (ER2) and internal rotation (level reached with the hand on the back).
Measured: Timepoints: screening, 6, 12, 24, 36 and 48 months
clinical change based on the DASH scale (disability of the arm, shoulder and Hand)
DASH (Disabilities of the arm, shoulder and Hand) rating card: is a questionnaire that asks to evaluate the difficulty in carrying out 30 daily tasks, bringing a score from 0 (best functionality) to 100 (worst functionality).
Measured: Timepoints: screening, 6, 12, 24, 36 and 48 months
clinical change based on the , American Shoulder and Elbow Surgeons (ASES) score
ASES (American shoulder and Elbow Surgeons shoulder Score) rating card: questionnaire that integrates the pain felt (rated on a scale of 0 to 10) and the ability to perform 10 daily activities in which the use of the arm is involved, reporting a score from 0 (worst functionality) to 100 (best functionality).
Measured: Timepoints: screening, 6, 12, 24, 36 and 48 months
evaluation of shoulder MRI results
Execution of a shoulder MRI for evaluation of joint cartilage by comparing it with the MRIs of previous time points.
Measured: 12 and 24 months
evaluation of shoulder X-ray (XR) results
Execution of a shoulder XR in antero-posterior (AP) projection to assess the progression of glenohumeral arthrosis.
Measured: 12, 24 and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start12 Nov 2019
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthritisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Castagna, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308213
- Sponsor's protocol ID
- 955
- Acronym
- Stemshoulder
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study on the Treatment of Shoulder Osteoarthritis With Intra-articular Injections of Autologous Bone Marrow Aspirate.
- ClinicalTrials.gov ID
- NCT04308213
- Acronym / sponsor ID
- Stemshoulder / 955
- Conditions
- Shoulder Arthritis
- Keywords
- arthritis, mesenchymal stem cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Mar 2020 (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.
Treatment of isolated osteoarthritis of the glenohumeral joint at the initial stages involves the use of numerous conservative or arthroscopic treatments with uncertain results and, upon their failure, the current solution for the resolution of symptoms is shoulder arthroplasty, an effective procedure but with significant costs and rates of morbidity, especially in young patients. Since the use of intra-articular injections of mesenchymal cells obtained from the bone marrow has proved effective in the treatment of gonarthrosis, our goal is to evaluate the effectiveness of the same therapy in the treatment of glenohumeral arthritis isolated.
Detailed description
Glenohumeral arthritis is one of the main reasons for persistent shoulder pain and reduced movement (range of motion, ROM) as it can compromise the work activity and also the normal daily activities, leading to the development of depressive syndromes. The final treatment is shoulder arthroplasty, which is effective but is associated with significant costs and morbidity rates. In addition, arthro-prosthesis is avoided in young patients due to longevity concerns and is not indicated in the early stages of arthritis. Currently, conservative treatments for patients with mild or moderate glenohumeral arthritis include non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, with low efficacy and a significant adverse effect profile, hyaluronic acid infiltrations, with good efficacy in initial treatment, and infiltrations of platelet-Rich Plasma (PRP), which have shown beneficial effects in knee arthritis. However, evidence for the glenohumeral joint are limited. In cases not responsive to conservative therapy, and especially in young patients, a valid alternative to the prosthesis is the arthroscopic treatment, with good results in the short term, but with relatively high failure rates that increase over time. Other types of nonprosthetic surgical treatment for chondral-humeral defects have low scientific evidence, with variable and uncertain results. In recent years, mesenchymal stem cells (MSC), derived from bone marrow or adipose tissue, due to the ability to differentiate into chondrogenic line cells, have emerged as cells with great therapeutic potential in patients with degenerative joint disorders. Since the knee joint is the most susceptible to pathology because of its mechanical load, most studies based on stem cell therapy regard the knee joint, reporting promising results in treatment in the treatment of early stages of arthritis. As regards the glenohumeral joint, since the most frequent pathology affects the tendons of the rotator cuff, almost all studies investigate the effect of MSC in the treatment of rotator cuff disorders with or without associated surgical repair techniques. Only a prospective study analyzed the effect of intra-articular MSC injection derived from bone marrow in 34 patients with isolated glenohumeral arthritis, reporting a significant decrease in pain and an improvement in shoulder function measured by the Disabilities of the Arm, Shoulder and Hand (DASH) scale at about 1 year, although study quality is very low. Since the use of intra-articular injections of mesenchymal cells obtained from the bone marrow has proved effective in the treatment of gonarthrosis, our study proposes to evaluate the long-term efficacy of this type of therapy in the treatment of the isolated glenohumeral arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow aspirate | Experimental | Device: Marrow Cellution SystemAll the patients enrolled in the study will be treated with the bone marrow aspirate obtained with the Bone Marrow Cellution Kit. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged between 35 and 75.
- Light or moderate glenohumeral arthritis assessed by MRI.
- Failure after at least 6 months of conservative treatment (patients not responding to drug therapy with NSAIDs and pain killers, no benefit from hydro-kinesitherapy or physiotherapy, no benefit after a course of hyaluronic acid or PRP infiltrations, or after at least one corticosteroid infiltration)
- Ability and consent of patients to participate actively in the rehabilitation and clinical and radiological follow-up protocol;
- The signing of informed consent.
Key exclusion criteria (11 listed)
- Patients incapable of understanding and will
- Patients with shoulder trauma within 6 months prior to surgery
- Patients with malignancies;
- Patients with rheumatic diseases;
- Patients with diabetes;
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 |
|---|---|---|
| Marrow Cellution SystemThe treatment will be carried out in the operating room under ordinary hospitalization and provides the intra-articular application of 9 ml of autologous bone marrow aspirate in the glenohumeral joint affected by arthrosis. To obtain the necessary amount, a bone marrow aspirate of about 12 ml will be taken from the iliac crest by means of the Marrow Cellution System, Geistlich Italia. This autologous bone marrow aspirate will be injected using the same syringe into the glenohumeral joint affected by arthrosis under amplioscopic control. | Device | Bone Marrow aspirate |
Primary outcome
Change of the Constant-Murley score
Time frame: Timepoints: Screening, 3, 6, 12, 24, 36, and 48 months
Constant-Murley score: is a scale of 100 points that defines the level of pain and the ability to perform normal daily activities of the patient. The test is divided into 4 subscales: pain (15 points), daily life activity (20 points), force (25 points), range of movement: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
Change of the VAS pain score
Time frame: Timepoints: Screening, 3, 6, 12, 24, 36, and 48 months
Visual analogue Scale (VAS): The patient is asked to quantify pain by indicating its intensity on an visual analog scale (0 no pain, 10 the worst pain).
5 secondary outcomes
Change of range of motion (ROM)
Time frame: Timepoints: screening, 6, 12, 24, 36 and 48 months
clinical change based on the DASH scale (disability of the arm, shoulder and Hand)
Time frame: Timepoints: screening, 6, 12, 24, 36 and 48 months
clinical change based on the , American Shoulder and Elbow Surgeons (ASES) score
Time frame: Timepoints: screening, 6, 12, 24, 36 and 48 months
evaluation of shoulder MRI results
Time frame: 12 and 24 months
evaluation of shoulder X-ray (XR) results
Time frame: 12, 24 and 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Shoulder Arthritis
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
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.
Alessandro Castagna, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marrow Cellution System in people with Shoulder Arthritis, run by Istituto Clinico Humanitas at 1 site in Italy.
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 5 inclusion and 11 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 17 Mar 2020. 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 Italy. 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. 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 Alessandro Castagna (+390282244663, alessandro.castagna@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Constant-Murley score (time frame: Timepoints: Screening, 3, 6, 12, 24, 36, and 48 months). The study lists 2 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 17 Mar 2020.