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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02770755

Acronym

ACHILLES

Enrollment

Registered

2016-05-12

Start date

2014-09-30

Completion date

2017-05-31

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Tear

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in magnitude of muscle tear as assessed by ultrasound or MRI	42 days

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Recurrent muscle tears	Days 7, 14, 21, 42 and 90	Number of recurrent muscle tears

Countries

United Kingdom

Outcome results