Status:
TERMINATED
Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy
Lead Sponsor:
Bioinova, s.r.o.
Collaborating Sponsors:
University Hospital, Motol
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 12 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03838666
Start Date
December 12 2012
End Date
November 18 2015
Last Update
February 15 2019
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