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Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy (AMSC-RC-001)

Primary Purpose

Rotator Cuff Tear

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Suspension of human autologous MSC 3P
Sponsored by
Bioinova, s.r.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. males or females between 40 and 65 years of age,
  2. written informed consent obtained,
  3. complete unilateral rotator cuff tear on pre-operative clinical and imaging findings,
  4. elected to undergo an arthroscopic repair of their rotator cuff tear,
  5. agreed to wear a dedicated brace for four weeks post-operatively,
  6. minimum pre-operative hemoglobin of 11.0 g/dl or more
  7. pre-operative platelet count greater than 150 000 / 1 mm3

Exclusion Criteria:

  1. a tear involving the subscapularis or biceps tendons,
  2. a previous rotator cuff repair,
  3. moderate-to-severe osteoarthritis of the glenohumeral joint,
  4. loss of passive elevation in any direction when compared to the contralateral shoulder,
  5. 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,
  6. a massive tear with a contracted immobile cuff confirmed in operation,
  7. an active infection, osteomyelitis or sepsis or distant infections which may spread to the site of operation,
  8. other diseases which may have limit follow-up (immunocompromising, hepatitis, active tuberculosis, neoplastic diseases, septic arthritis),
  9. osteomalacia or other metabolic bone disorders which may impair bone or soft tissue function,
  10. vascular insufficiency, muscular atrophy or neuromuscular diseases of the affected arm,
  11. haemato/oncological diseases,
  12. pregnant or lactating women,
  13. alcohol or drug abusers,
  14. patients on corticosteroids, immunosuppressants or anticoagulant therapy,
  15. 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,
  16. fertile men not using proven contraceptive measures including effective contraception of their partners (established oral contraception, intrauterine device, ligation of the uterine tube).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Suspension of human autologous MSC 3P

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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
    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,

    Full Information

    First Posted
    January 14, 2019
    Last Updated
    February 12, 2019
    Sponsor
    Bioinova, s.r.o.
    Collaborators
    Department of Neurology, University Hospital Motol, Prague, Czech Republic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03838666
    Brief Title
    Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy
    Acronym
    AMSC-RC-001
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Terminated
    Why Stopped
    Primary endpoint (safety) has been achieved
    Study Start Date
    December 12, 2012 (Actual)
    Primary Completion Date
    November 18, 2015 (Actual)
    Study Completion Date
    November 18, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bioinova, s.r.o.
    Collaborators
    Department of Neurology, University Hospital Motol, Prague, Czech Republic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tear

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Suspension of human autologous MSC 3P
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Suspension of human autologous MSC 3P
    Other Intervention Name(s)
    hAMSC
    Intervention Description
    Single administration of the suspension of human autologous MSC 3P in 1.5 ml on the surface of the repaired rotator cuff tendon
    Primary Outcome Measure Information:
    Title
    Safety: To assess the occurrence of adverse events of treatment by hAMSC - systemic reactions.
    Description
    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.
    Time Frame
    1 year
    Title
    Safety: To assess the occurrence of adverse events of treatment by autologous mesenchymal stem cells - local reactions.
    Description
    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.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - Visual Analogue Score (VAS)
    Description
    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.
    Time Frame
    1 year
    Title
    Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - Constant Shoulder Score
    Description
    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.
    Time Frame
    1 year
    Title
    Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - UCLA Shoulder Rating Score
    Description
    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.
    Time Frame
    1 year
    Title
    Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - MRI imaging - Continuation / discontinuation of the rotator cuff
    Description
    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
    Time Frame
    1 year
    Title
    Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - MRI imaging - Fatty degeneration
    Description
    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,
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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, 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Petr Lesny, MD
    Organizational Affiliation
    Bioinova, s.r.o.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data has been published

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