Rotator Cuff TearPhase 1/2AMSC-RC-001NCT03838666
Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy
A Phase 1/2 study testing Suspension of human autologous MSC 3P in people with Rotator Cuff Tear, run by Bioinova, s.r.o..
Trial summary
Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see below). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Suspension of human autologous MSC 3P
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2012to 18 Nov 2015
- Phase
- Phase 1/2
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males or females between 40 and 65 years of age,
- written informed consent obtained,
- complete unilateral rotator cuff tear on pre-operative clinical and imaging findings,
- elected to undergo an arthroscopic repair of their rotator cuff tear,
- agreed to wear a dedicated brace for four weeks post-operatively,
- minimum pre-operative hemoglobin of 11.0 g/dl or more
- pre-operative platelet count greater than 150 000 / 1 mm3
Who cannot join
- a tear involving the subscapularis or biceps tendons,
- a previous rotator cuff repair,
- moderate-to-severe osteoarthritis of the glenohumeral joint,
- loss of passive elevation in any direction when compared to the contralateral shoulder,
- fatty infiltration greater than 50 % of the cross-sectional area of supraspinatus or infraspinatus assessed on the most lateral image on which the scapular spine is in contact with the scapular body,
- a massive tear with a contracted immobile cuff confirmed in operation,
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- an active infection, osteomyelitis or sepsis or distant infections which may spread to the site of operation,
- other diseases which may have limit follow-up (immunocompromising, hepatitis, active tuberculosis, neoplastic diseases, septic arthritis),
- osteomalacia or other metabolic bone disorders which may impair bone or soft tissue function,
- vascular insufficiency, muscular atrophy or neuromuscular diseases of the affected arm,
- haemato/oncological diseases,
- pregnant or lactating women,
- alcohol or drug abusers,
- patients on corticosteroids, immunosuppressants or anticoagulant therapy,
- women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
- fertile men not using proven contraceptive measures including effective contraception of their partners (established oral contraception, intrauterine device, ligation of the uterine tube).
About this study
Official title: Utilization of Autologous Mesenchymal Cells to Enhance Rotator Cuff Repair - a Prospective Non-randomized, Open-Label Study to Assess the Safety and the Efficacy
Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see below). Each patient will undergo post-operative follow-up at 6 weeks, 6 months and 12 months after the surgery. This will include a visual analogue score for pain (VAS), a questionnaire for the subjective Constant shoulder score, and the subjective questions of the University of California (UCLA) score. Preoperative and postoperative MRI at 12 months will be done to evaluate the quality of the rotator cuff repair.
Read the detailed description
Eligible patients will undergo an arthroscopic rotator cuff repair augmented by mesenchymal stem cells (MSCs). The primary objective of the trial is to assess the safety and tolerability of autologous mesenchymal stem cells treatment applied during arthroscopic rotator cuff repair.
The condition of the patient will be monitored throughout the study. At each visit, adverse events (AEs) will be elicited using a standard non-leading questions. In addition, any signs or symptoms will be observed. All AEs will be collected as:
- patient's positive response to questions about their health
- symptoms spontaneously reported by the patient
- clinically relevant changes and abnormalities observed by the Investigator (e.g. local and systemic tolerability, clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations).
Clinical improvement will be measured by clinical outcome scores (Constant shoulder score and UCLA Shoulder rating scale) at 6 weeks, 6 months and 1 year after the surgery. MRI (Magnetic Resonance Imaging) findings made preoperatively and at 12 months (1 year) after operation will be evaluated.
During the indication visit, patient's history will be taken and preoperative MRI evaluated. Written consent form will be collected from the patient after detailed education of the patient by the investigator.
- Conditions
- Rotator Cuff Tear
- Being tested
- Suspension of human autologous MSC 3P
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suspension of human autologous MSC 3PDrug
Also called hAMSC
Single administration of the suspension of human autologous MSC 3P in 1.5 ml on the surface of the repaired rotator cuff tendon
| Study group | Role | What they receive |
|---|---|---|
| Suspension of human autologous MSC 3P | Experimental | Patients will receive perioperative hAMSC (1.5 ml) treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon. Receives: Drug: Suspension of human autologous MSC 3P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To assess the occurrence of adverse events of treatment by hAMSC - systemic reactions.
Safety and tolerability of hAMSC treatment applied during the surgical rotator cuff repair will be recorded - systemic reactions including allergic reaction or sepsis at Visits I through VI.
Measured: 1 year
Safety: To assess the occurrence of adverse events of treatment by autologous mesenchymal stem cells - local reactions.
Safety and tolerability of autologous mesenchymal stem cells treatment applied during the surgical rotator cuff repair will be recorded - local reactions including pain, bleeding, local infection at Visits I through VI.
Measured: 1 year
Secondary outcomes (5)
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - Visual Analogue Score (VAS)
The efficacy analysis will be evaluated by comparing pre- and post-treatment rotator cuff function measured by changes in Visual Analogue Score (VAS) (meter-shaped scale; in mm) at Visits II, IV, V, and VI.
VAS is a self-report measure consisting simply of a 10 centimeter line with a statement at each end representing one extreme of the dimension being measured (most often intensity of pain). The respondent gives their indication with a pen mark on the line corresponding to their answer, e.g. the present pain level.
Measured: 1 year
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - Constant Shoulder Score
The secondary efficacy analysis will be evaluated by comparing pre- and post-treatment rotator cuff function by changes in Constant Shoulder Score (points) at Visits II, IV, V, and VI.
Measurements: Pain, Activities of daily living, Range of movement (forward flexion, abduction, external rotation, internal rotation), Power.
Less points (out of 100) means more severe condition.
Measured: 1 year
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - UCLA Shoulder Rating Score
The secondary efficacy analysis will be evaluated by comparing pre- and post-treatment rotator cuff function by changes in UCLA Shoulder Rating Score (points) at Visits II, IV, V, and VI.
Measurements: Pain, Function, Active forward flexion, Strength of forward flexion (manual muscle-testing), Satisfaction of patient.
Less points (out of 35) means more severe condition.
Measured: 1 year
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - MRI imaging - Continuation / discontinuation of the rotator cuff
The secondary efficacy analysis will be evaluated by comparing pre- and post-treatment rotator cuff function which measured by MRI imaging (preoperative and at Visit VI) to evaluate the quality of the rotator cuff repair.
Following finding will be recorded:
- Continuation / discontinuation of the rotator cuff
- preoperatively - confirmation of complete unilateral rotator cuff tear
- 1 year after the treatment (Visit VI) - the quality and extent of rotator cuff repair - no recovery/partial recovery/full recovery
Measured: 1 year
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - MRI imaging - Fatty degeneration
The secondary efficacy analysis will be evaluated by comparing pre- and post-treatment rotator cuff function which measured by MRI imaging (preoperative and at Visit VI) to evaluate the quality of the rotator cuff repair.
Following finding will be recorded:
- Amount of fatty degeneration - percentage of fatty infiltration of the cross sectional area of supraspinatus or infraspinatus assessed on the most lateral image on which the scapular spine is in contact with the scapular body,
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start12 Dec 2012
- Primary completion18 Nov 2015
- Study completion18 Nov 2015
Why it stopped: Primary endpoint (safety) has been achieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioinova, s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Motol
- Responsible party
- Sponsor
- Investigators
- Petr Lesny, MD, Study chair, Bioinova, s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838666
- Sponsor's protocol ID
- AMSC-RC-001
- Acronym
- AMSC-RC-001
- Status last verified
- Feb 2019
- First submitted
- 14 Jan 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data has been published
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Autologous Mesenchymal Cells to Enhance Rotator Cuff Repair - a Prospective Non-randomized, Open-Label Study to Assess the Safety and the Efficacy
- ClinicalTrials.gov ID
- NCT03838666
- Acronym / sponsor ID
- AMSC-RC-001 / AMSC-RC-001
- Conditions
- Rotator Cuff Tear
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary endpoint (safety) has been achieved
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bioinova, s.r.o.Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Motol
- Study start
- 12 Dec 2012 (actual)
- Primary completion
- 18 Nov 2015 (actual)
- Study completion
- 18 Nov 2015 (actual)
- First posted
- 12 Feb 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.
Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see below). Each patient will undergo post-operative follow-up at 6 weeks, 6 months and 12 months after the surgery. This will include a visual analogue score for pain (VAS), a questionnaire for the subjective Constant shoulder score, and the subjective questions of the University of California (UCLA) score. Preoperative and postoperative MRI at 12 months will be done to evaluate the quality of the rotator cuff repair.
Detailed description
Eligible patients will undergo an arthroscopic rotator cuff repair augmented by mesenchymal stem cells (MSCs). The primary objective of the trial is to assess the safety and tolerability of autologous mesenchymal stem cells treatment applied during arthroscopic rotator cuff repair.
The condition of the patient will be monitored throughout the study. At each visit, adverse events (AEs) will be elicited using a standard non-leading questions. In addition, any signs or symptoms will be observed. All AEs will be collected as:
- patient's positive response to questions about their health
- symptoms spontaneously reported by the patient
- clinically relevant changes and abnormalities observed by the Investigator (e.g. local and systemic tolerability, clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations).
Clinical improvement will be measured by clinical outcome scores (Constant shoulder score and UCLA Shoulder rating scale) at 6 weeks, 6 months and 1 year after the surgery. MRI (Magnetic Resonance Imaging) findings made preoperatively and at 12 months (1 year) after operation will be evaluated.
During the indication visit, patient's history will be taken and preoperative MRI evaluated. Written consent form will be collected from the patient after detailed education of the patient by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspension of human autologous MSC 3P | Experimental | Drug: Suspension of human autologous MSC 3PPatients will receive perioperative hAMSC (1.5 ml) treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- males or females between 40 and 65 years of age,
- written informed consent obtained,
- complete unilateral rotator cuff tear on pre-operative clinical and imaging findings,
- elected to undergo an arthroscopic repair of their rotator cuff tear,
- agreed to wear a dedicated brace for four weeks post-operatively,
Key exclusion criteria (16 listed)
- a tear involving the subscapularis or biceps tendons,
- a previous rotator cuff repair,
- moderate-to-severe osteoarthritis of the glenohumeral joint,
- loss of passive elevation in any direction when compared to the contralateral shoulder,
- fatty infiltration greater than 50 % of the cross-sectional area of supraspinatus or infraspinatus assessed on the most lateral image on which the scapular spine is in contact with the scapular body,
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 |
|---|---|---|
| Suspension of human autologous MSC 3PAlso: hAMSCSingle administration of the suspension of human autologous MSC 3P in 1.5 ml on the surface of the repaired rotator cuff tendon | Drug | Suspension of human autologous MSC 3P |
Primary outcome
Safety: To assess the occurrence of adverse events of treatment by hAMSC - systemic reactions.
Time frame: 1 year
Safety and tolerability of hAMSC treatment applied during the surgical rotator cuff repair will be recorded - systemic reactions including allergic reaction or sepsis at Visits I through VI.
Safety: To assess the occurrence of adverse events of treatment by autologous mesenchymal stem cells - local reactions.
Time frame: 1 year
Safety and tolerability of autologous mesenchymal stem cells treatment applied during the surgical rotator cuff repair will be recorded - local reactions including pain, bleeding, local infection at Visits I through VI.
5 secondary outcomes
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - Visual Analogue Score (VAS)
Time frame: 1 year
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - Constant Shoulder Score
Time frame: 1 year
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - UCLA Shoulder Rating Score
Time frame: 1 year
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - MRI imaging - Continuation / discontinuation of the rotator cuff
Time frame: 1 year
Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - MRI imaging - Fatty degeneration
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Primary endpoint (safety) has been achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No. The data has been published
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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.
Petr Lesny, MD study chair
Bioinova, s.r.o.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Suspension of human autologous MSC 3P in people with Rotator Cuff Tear, run by Bioinova, s.r.o..
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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 15 Feb 2019. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Primary endpoint (safety) has been achieved). Results are not available in the source record.
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?
Safety: To assess the occurrence of adverse events of treatment by hAMSC - systemic reactions. (time frame: 1 year). 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 15 Feb 2019.