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

May 11, 2016 updated by: Cytori Therapeutics

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in magnitude of muscle tear as assessed by ultrasound or MRI
Time Frame: 21 days
21 days
% of patients with complete healing as measured by ultrasound or MRI
Time Frame: Days 7, 14, 21, 42 and 90
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
Days 7, 14, 21, 42 and 90
Change in function
Time Frame: Days 7, 14, 21, 42 and 90
Change in function assessed via patient questionnaires
Days 7, 14, 21, 42 and 90

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytori Therapeutics

Investigators

  • Study Chair: Steven Kesten, M.D., Cytori Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACHILLES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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