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

NCT03838666 | Terminated Phase 1

• 1 other identifier: AMSC-RC-001
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  1 year

Secondary Outcomes (5)

• Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - Visual Analogue Score (VAS)

  1 year

• Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - Constant Shoulder Score

  1 year

• Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - UCLA Shoulder Rating Score

  1 year

• Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - MRI imaging - Continuation / discontinuation of the rotator cuff

  1 year

• Efficacy: To evaluate the effect of hAMSCs applied during arthroscopic rotator cuff repair - MRI imaging - Fatty degeneration

  1 year

Study Arms (1)

Suspension of human autologous MSC 3P

EXPERIMENTAL

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.

Drug: Suspension of human autologous MSC 3P

Interventions

Suspension of human autologous MSC 3P DRUG

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

Also known as: hAMSC

Suspension of human autologous MSC 3P

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Bioinova, s.r.o.: lead
• University Hospital, Motol: collaborator

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Petr Lesny, MD

  Bioinova, s.r.o.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: February 12, 2019
• Study Start: December 12, 2012
• Primary Completion: November 18, 2015
• Study Completion: November 18, 2015
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share