Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy

• Status: Terminated
• Trial end date: 2015-11-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioinova, s.r.o.
• Collaborator: Department of Neurology, University Hospital Motol, Prague, Czech Republic

Criteria

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).