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

NCT ID: NCT02770755

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-05-31

Brief Summary

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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 Description

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Conditions

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Muscle Tear

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytori Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Kesten, M.D.

Role: STUDY_CHAIR

Cytori Therapeutics

Locations

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The Football Association

Wembley, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ACHILLES

Identifier Type: -

Identifier Source: org_study_id

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