NCT02770755

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

March 15, 2016

Last Update Submit

May 11, 2016

Conditions

Muscle Tear

Outcome Measures

Primary Outcomes (1)

  • Change in magnitude of muscle tear as assessed by ultrasound or MRI

    42 days

Secondary Outcomes (4)

  • 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

  • Change in pain

    Days 7, 14, 21, 42 and 90

  • Change in function

    Days 7, 14, 21, 42 and 90

Other Outcomes (1)

  • Recurrent muscle tears

    Days 7, 14, 21, 42 and 90

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Football Association

Wembley, United Kingdom

Location

Study Officials

  • Steven Kesten, M.D.

    Cytori Therapeutics

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

May 12, 2016

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

May 1, 2017

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

GB(1)