Registry of Celution Device for Processing ADRCs and Heal... | NCT02770755

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

NCT02770755

Sponsor

Cytori Therapeutics

Status

Withdrawn

Last Update Posted

May 12, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Muscle Tear

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Corporate decision

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jun 2016Estimated

Completion Date

May 2017Estimated

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

May 11, 2016

First Posted Date

May 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 12, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample