Study on Shoulder Arthritis Treatment With Intra-articular Injections of Autologous Bone Marrow Aspirate. (Stemshoulder)

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Arthritis
• Intervention / Treatment: Device: Marrow Cellution System

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro Castagna; Phone Number: +390282244663; Email: alessandro.castagna@humanitas.it

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients aged between 35 and 75.
2. Light or moderate glenohumeral arthritis assessed by MRI.
3. 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)
4. Ability and consent of patients to participate actively in the rehabilitation and clinical and radiological follow-up protocol;
5. The signing of informed consent.

Exclusion Criteria:

1. Patients incapable of understanding and will
2. Patients with shoulder trauma within 6 months prior to surgery
3. Patients with malignancies;
4. Patients with rheumatic diseases;
5. Patients with diabetes;
6. Patients with metabolic thyroid disorders;
7. Patients abusing alcoholic beverages, drugs or drugs;
8. Patients with signs of rotator cuff or long head biceps disease at MRI
9. Patients with a history of untreated shoulder instability.
10. Patients with arthroscopic evidence of rotator cuff injuries.
11. Glenohumeral arthrosis "bone to bone".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Bone Marrow aspirate; All the patients enrolled in the study will be treated with the bone marrow aspirate obtained with the Bone Marrow Cellution Kit.

Device: Marrow Cellution System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Timepoints: Screening, 3, 6, 12, 24, 36, and 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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.	12, 24 and 48 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2019
• Primary Completion (ANTICIPATED): April 30, 2024
• Study Completion (ANTICIPATED): September 30, 2024

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (ACTUAL): March 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: mesenchymal stem cells; arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No