Muscle TearACHILLESNCT02770755
Registry of Celution Device for Processing ADRCs and Healing in Muscle and Ligament Sports Injuries
An observational study of Muscle Tear, run by Cytori Therapeutics at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Tear
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to May 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Muscle Tear
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in magnitude of muscle tear as assessed by ultrasound or MRI
Measured: 42 days
Secondary outcomes (4)
Change in magnitude of muscle tear as assessed by ultrasound or MRI
Measured: 21 days
% of patients with complete healing as measured by ultrasound or MRI
Measured: Days 7, 14, 21, 42 and 90
Change in pain
Change in pain assessed via patient questionnaires
Measured: Days 7, 14, 21, 42 and 90
Change in function
Change in function assessed via patient questionnaires
Measured: Days 7, 14, 21, 42 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2016 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Corporate decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kesten, M.D., Study chair, Cytori Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770755
- Sponsor's protocol ID
- ACHILLES
- Acronym
- ACHILLES
- Status last verified
- May 2016
- First submitted
- 15 Mar 2016
- Last updated
- 12 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) and Healing in Muscle and Ligament Sports Injuries (ACHILLES)
- ClinicalTrials.gov ID
- NCT02770755
- Acronym / sponsor ID
- ACHILLES / ACHILLES
- Conditions
- Muscle Tear
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Corporate decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in magnitude of muscle tear as assessed by ultrasound or MRI
Time frame: 42 days
4 secondary outcomes
Change in magnitude of muscle tear as assessed by ultrasound or MRI
Time frame: 21 days
% of patients with complete healing as measured by ultrasound or MRI
Time frame: Days 7, 14, 21, 42 and 90
Change in pain
Time frame: Days 7, 14, 21, 42 and 90
Change in function
Time frame: Days 7, 14, 21, 42 and 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Kesten, M.D. study chair
Cytori Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Tear, run by Cytori Therapeutics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in magnitude of muscle tear as assessed by ultrasound or MRI (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.