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Trial record 3 of 3110 for:    "Osteoarthritis"

Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) to Treat Osteoarthritis (RELIEVE)

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ClinicalTrials.gov Identifier: NCT02736110
Recruitment Status : Withdrawn (Corporate decision)
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Brief 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.

Condition or disease
Osteoarthritis

Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) for Intra-articular Delivery to Knees With Osteoarthritis
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis




Primary Outcome Measures :
  1. Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS) [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS) [ Time Frame: Days 7, 30, 180 and 365 ]
  2. Change in knee pain assessed by VAS Assessments [ Time Frame: Days 7, 30, 90, 180 and 365 ]
  3. Change in knee function as assessed by the Lysholm Knee Scoring Scale [ Time Frame: Days 7, 30, 90, 180 and 365 ]
  4. Change in WORMS scoring (Whole Organ MRI of the knee) [ Time Frame: Days 180 and 365 ]
  5. Change in knee function as measured by Tegner Activity Scale [ Time Frame: Days 7, 30, 90, 180 and 365 ]
  6. Change in knee function as measured by the Lower Extremity Functional Scale [ Time Frame: Days 7, 30, 90, 180 and 365 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736110


Sponsors and Collaborators
Cytori Therapeutics
Investigators
Study Chair: Steven Kesten Cytori Therapeutics

Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT02736110     History of Changes
Other Study ID Numbers: RELIEVE
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Cytori Therapeutics:
Osteoarthritis, knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases