Treatment of Damaged Shoulder Joint by Stem Cells.

Phase 1

• Conditions: Complete unilateral rotator cuff tear; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-024664-17-CZ
• Lead Sponsor: Bioinova, s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-06
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 haemoglobin of 11.0 g/dl or more,
7. pre-operative platelet count greater than 150 000 / 1 mm3.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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 (immunocompromission, 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. pregnant or lactating women,
12. alcohol or drug abusers,
13. patients on corticosteroids (7 days before operation), immunosuppressants (3 months before operation) or anticoagulant therapy (7 days before operation),
14.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,
15.fertile men not using proven contraceptive measures including effective contraception of their partner (established oral contraception, intrauterine device, ligation of the uterine tube).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of autologous mesenchymal stem cells treatment applied during arthroscopic rotator cuff repair.;Secondary Objective: To evaluate the clinical improvement obtained by this clinical trial in order to determine the statistical procedures for the subsequent clinical trials. The clinical improvement augmented by autologous mesenchymal stem cells will be measured by clinical outcome scores (Constant and UCLA) at 6 weeks, 6 months and 1 year and the quality of repair by MRI findings 12 months after surgery in comparison with the pre-operative MRI.<br>We also note the incidence of other treatment – emergent adverse events. <br>;Primary end point(s): Safety: To assess safety and tolerability of AMSC treatment at the site of torn rotator cuff. Evaluation of all adverse events collected during the course of the trial.<br>;Timepoint(s) of evaluation of this end point: At 6 weeks, 6 months and 1 year after surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy: To assess clinical improvement after rotator cuff repair augmented by MSCs measured by clinical outcome scores (VAS, Constant and UCLA) at 6 weeks, 6 months and 1 year and the quality of repair by MRI findings 12 months after surgery in comparison with the pre-operative MRI.;Timepoint(s) of evaluation of this end point: At 6 weeks, 6 months and 1 year after surgery.