Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) and Healing in Muscle and Ligament Sports Injuries (ACHILLES)

Cytori Therapeutics1 site in 1 countrySeptember 2014

ConditionsMuscle Tear

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Muscle Tear
Sponsor: Cytori Therapeutics
Locations: 1
Primary Endpoint: Change in magnitude of muscle tear as assessed by ultrasound or MRI
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

May 2017

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cytori Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in magnitude of muscle tear as assessed by ultrasound or MRI

Time Frame: 42 days

Secondary Outcomes

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 function(Days 7, 14, 21, 42 and 90)