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

NCT ID: NCT03838666

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-12
• Study Completion Date: 2015-11-18

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.

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Suspension of human autologous MSC 3P

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.

Group Type: EXPERIMENTAL

Suspension of human autologous MSC 3P

Intervention Type: DRUG

Single administration of the suspension of human autologous MSC 3P in 1.5 ml on the surface of the repaired rotator cuff tendon

Interventions

Suspension of human autologous MSC 3P

Single administration of the suspension of human autologous MSC 3P in 1.5 ml on the surface of the repaired rotator cuff tendon

Intervention Type: DRUG

Other Intervention Names

hAMSC

Eligibility 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: collaborator

Bioinova, s.r.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petr Lesny, MD

Role: STUDY_CHAIR

Bioinova, s.r.o.

Other Identifiers

AMSC-RC-001

Identifier Type: -

Identifier Source: org_study_id