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

Cytori Therapeutics

Status: Withdrawn

Conditions: Muscle Tear

Study type: Observational

Funder types: Industry

Identifiers

NCT02770755

ACHILLES

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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