Clinical Trial: Registry of Celution Device for Processing ADRCs and Healing in Muscle and Ligament Sports Injuries
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational [Patient Registry]
Official Title: Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) and Healing in Muscle and Ligament Sports Injuries (ACHILLES)
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 Summary:
Sponsor: Cytori Therapeutics
Current Primary Outcome: Change in magnitude of muscle tear as assessed by ultrasound or MRI [ Time Frame: 42 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in magnitude of muscle tear as assessed by ultrasound or MRI [ Time Frame: 21 days ]
- % of patients with complete healing as measured by ultrasound or MRI [ Time Frame: Days 7, 14, 21, 42 and 90 ]
- Change in pain [ Time Frame: Days 7, 14, 21, 42 and 90 ]Change in pain assessed via patient questionnaires
- Change in function [ Time Frame: Days 7, 14, 21, 42 and 90 ]Change in function assessed via patient questionnaires
Original Secondary Outcome: Same as current
Information By: Cytori Therapeutics
Dates:
Date Received: March 15, 2016
Date Started: September 2014
Date Completion: May 2017
Last Updated: May 11, 2016
Last Verified: May 2016
