OsteoarthritisRELIEVENCT02736110
Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) to Treat Osteoarthritis
An observational study of Osteoarthritis, run by Cytori Therapeutics.
Trial summary
This registry study will compile information from patients that are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jul 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 that are schedule to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.
Who may be able to join
- Males or females > 18 years of age
- Diagnosis of osteoarthritis in one or both knees with Kellgren Lawrence grade ≥ 2 at x-ray evaluation or MRI findings of degenerative changes
- Pain with or without swelling in the affected area for >4 months
Who cannot join
- Know spine or disc disease or symptomatic nerve impingement contributing to pain in the affected limb
- History of documented nerve damage in the affected limb
- Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test prior to procedure.
About this study
Official title: Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) for Intra-articular Delivery to Knees With Osteoarthritis
This registry study will compile information from patients that are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, knee
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
Measured: 90 days
Secondary outcomes (6)
Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
Measured: Days 7, 30, 180 and 365
Change in knee pain assessed by VAS Assessments
Measured: Days 7, 30, 90, 180 and 365
Change in knee function as assessed by the Lysholm Knee Scoring Scale
Measured: Days 7, 30, 90, 180 and 365
Change in WORMS scoring (Whole Organ MRI of the knee)
Measured: Days 180 and 365
Change in knee function as measured by Tegner Activity Scale
Measured: Days 7, 30, 90, 180 and 365
Change in knee function as measured by the Lower Extremity Functional Scale
Measured: Days 7, 30, 90, 180 and 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionJul 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 OsteoarthritisStudies 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, Study chair, Cytori Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736110
- Sponsor's protocol ID
- RELIEVE
- Acronym
- RELIEVE
- Status last verified
- Apr 2016
- First submitted
- 15 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 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) for Intra-articular Delivery to Knees With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02736110
- Acronym / sponsor ID
- RELIEVE / RELIEVE
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, knee
- 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
- Sep 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 13 Apr 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 from patients that are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.
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 that are schedule to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.
Key inclusion criteria (3 listed)
- Males or females > 18 years of age
- Diagnosis of osteoarthritis in one or both knees with Kellgren Lawrence grade ≥ 2 at x-ray evaluation or MRI findings of degenerative changes
- Pain with or without swelling in the affected area for >4 months
Key exclusion criteria (3 listed)
- Know spine or disc disease or symptomatic nerve impingement contributing to pain in the affected limb
- History of documented nerve damage in the affected limb
- Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test prior to procedure.
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 knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
Time frame: 90 days
6 secondary outcomes
Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
Time frame: Days 7, 30, 180 and 365
Change in knee pain assessed by VAS Assessments
Time frame: Days 7, 30, 90, 180 and 365
Change in knee function as assessed by the Lysholm Knee Scoring Scale
Time frame: Days 7, 30, 90, 180 and 365
Change in WORMS scoring (Whole Organ MRI of the knee)
Time frame: Days 180 and 365
Change in knee function as measured by Tegner Activity Scale
Time frame: Days 7, 30, 90, 180 and 365
Change in knee function as measured by the Lower Extremity Functional Scale
Time frame: Days 7, 30, 90, 180 and 365
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 13 Apr 2016.
- Individual participant dataSharing planned: Yes
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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 study chair
Cytori Therapeutics
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Cytori Therapeutics.
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 3 inclusion and 3 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 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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 knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS) (time frame: 90 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 13 Apr 2016.