Registry of Celution Device for Processing ADRCs and Healing in Muscle and Ligament Sports Injuries

Withdrawn

• Conditions: Muscle Tear

• Registration Number: NCT02770755
• Lead Sponsor: Cytori Therapeutics

Brief Summary

This registry study will compile information about patients who are scheduled to receive or have received Adipose Derived Regenerative cells (ADRCs) prepared by Celution device to treat muscle and ligament sports injuries.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-03-15
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Study First Posted: 2016-05-12
• Last Update Posted: 2016-05-12
• Primary Completion: 2016-06
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Males or females > 18 of age
• Patients with sports related muscle tear (≥5%) with or without ligament injury as confirmed by ultrasound or MRI with onset of injury in preceding year
• Pain in the affected area at rest and/or movement
• Weakness or inability to use affected muscle

Exclusion Criteria

• Muscle tear <5% or unrepaired complete tears or ruptures on ultrasound or MRI
• Known spine or disc disease or symptomatic impingement of nerve root
• Known neuromuscular disease (e.g., amyotrophic lateral sclerosis, muscular dystrophy)
• History of documented nerve damage in the affected limb
• Tears involving open wounds
• Tears requiring surgical repair
• Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in magnitude of muscle tear as assessed by ultrasound or MRI	42 days

Secondary Outcome Measures

Name	Time	Method
Change in magnitude of muscle tear as assessed by ultrasound or MRI	21 days
% of patients with complete healing as measured by ultrasound or MRI	Days 7, 14, 21, 42 and 90
Change in pain	Days 7, 14, 21, 42 and 90	Change in pain assessed via patient questionnaires
Change in function	Days 7, 14, 21, 42 and 90	Change in function assessed via patient questionnaires

Trial Locations

Locations (1)

The Football Association; 🇬🇧 Wembley, United Kingdom