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

Muscle Tear Clinical Trial

— ACHILLES  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02770755
• Other study ID #: ACHILLES
• Status: Withdrawn
• Phase: N/A
• First received: March 15, 2016
• Last updated: May 11, 2016
• Start date: September 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2016
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Muscle Tear

Locations

Country	Name	City	State
United Kingdom	The Football Association	Wembley

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrent muscle tears	Number of recurrent muscle tears	Days 7, 14, 21, 42 and 90	Yes
Primary	Change in magnitude of muscle tear as assessed by ultrasound or MRI		42 days	No
Secondary	Change in magnitude of muscle tear as assessed by ultrasound or MRI		21 days	No
Secondary	% of patients with complete healing as measured by ultrasound or MRI		Days 7, 14, 21, 42 and 90	No
Secondary	Change in pain	Change in pain assessed via patient questionnaires	Days 7, 14, 21, 42 and 90	No
Secondary	Change in function	Change in function assessed via patient questionnaires	Days 7, 14, 21, 42 and 90	No