Osteoarthritis, KneePhase 2ACT-OA KneeNCT02326961
Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee
A Phase 2 study testing Celution Device in people with Osteoarthritis, Knee, run by Cytori Therapeutics at 11 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and feasibility of intraarticular injection of Celution prepared adipose-derived regenerative cells injected into knees of patients with chronic knee pain due to osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Celution Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2015to Oct 2016
- Phase
- Phase 2
- 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 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥ 40 and < 70 years of age
- Able to provide written informed consent
- Diagnosis of osteoarthritis in one or both knees by American College of Rheumatology (ACR) criteria
- Kellgren and Lawrence grade 2 or 3 (standing AP x-ray) of the target knee within the preceding 6 months
- Pain due to osteoarthritis in the target knee ≥ 6 months
- Minimum score of "moderate" from KOOS question about pain on walking on a flat surface.
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- Minimum score of "moderate" from KOOS question about degree of difficulty during walking on a flat surface.
- Continued knee pain and limitations in knee function despite prescription of conservative therapy for at least 6 months.
- Ability to safely undergo liposuction that will result in the harvest of a sufficient quantity of adipose tissue (approximately 300 mL)
- On stable regimen of one analgesic medication (rescue medication) for their knee pain due to osteoarthritis and ability and willingness to use the same analgesic medication during the study (screening period through to final study visit).
- Ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs)
Who cannot join
- Any major injury to the target knee within the 12 months prior to the screening visit
- Need for cane or other assistance device for walking
- Any surgery to the target knee within the 6 months prior to the screening visit, or surgery to the contralateral knee or other weight-bearing joint if it will interfere with knee assessments
- Prior articular transplant procedures
- Prior ligament reconstruction to the target knee within 12 months prior to the screening visit
- Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
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- Gout or calcium pyrophosphate (pseudogout) diseases that have flared within the previous 6 months prior to the screening visit
- X-ray findings of acute fractures, known severe loss of bone density (as determined by the investigator), avascular necrosis, and/or severe bone or joint deformity in the target knee (>5 degree valgus or varus deviation from mechanical axis)
- Fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
- Primary knee pain due to diagnosed isolated patella-femoral arthritis or chondromalacia in the target knee
- Significant target knee joint infection or skin disorder/infection within the previous 6 months prior to the screening visit
- Symptomatic OA of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee
- Any condition requiring immunosuppressive medication or use of systemic steroids
- Intra-articular injection of steroids in previous 3 months or hyaluronic acid in previous 6 months in one or both knees prior to the screening visit
- Patients that have received PRP, other platelet-based product, or investigational treatment in another cell/biologic study for the targeted treatment injury in the 12 months prior to the injection procedure
- Participation in any experimental drug or device study within the 6 months prior to the screening visit
- Obesity defined as BMI > 35 kg/m2
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Rush University Medical Center
Chicago, Illinois, 60612
Covington Orthopedic and Sports Medicine Institute
Covington, Louisiana, 70433
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arthritis Treatment Center
Frederick, Maryland, 21702
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
BioSolutions Clinical Research Center
La Mesa, California, 91942
Central Kentucky Research Associates
Lexington, Kentucky, 40509
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Arizona Arthritis and Rheumatology Research, PLLC
Mesa, Arizona, 85202
Hospital for Special Surgery
New York, New York, 10021
Heartland Research Associates
Wichita, Kansas, 67207
About this study
Official title: Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee: A Double-blind, Placebo Controlled, Multi-center Safety and Feasibility Study
The primary objective of this study is to evaluate the safety and feasibility of intraarticular injection of Celution prepared adipose-derived regenerative cells injected into knees of patients with chronic knee pain due to osteoarthritis.
Read the detailed description
The ACT - OA Knee Clinical Trial is a prospective, randomized, multi-center device trial intended to assess safety and feasibility of intraarticular administration of Celution processed Adipose Derived Regenerative Cells (ADRCs). The study will include 90 patients in up to 15 sites in the United States.
Subjects that have chronic knee pain due to idiopathic osteoarthritis of the knee (confirmed clinically and radiologically) will be evaluated for eligibility in this study. Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo fat harvest through small volume liposuction under local anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for immediate intraarticular administration. A dose escalation approach has been designed wherein the study is divided into two double-blind, randomized, placebo-controlled parts as follows:
Part A:
Low Dose (20,000,000 cells): 30 patients OR Placebo: 15 patients
Part B:
High Dose (40,000,000 cells): 30 patients OR Placebo: 15 patients
Subjects randomized to placebo will undergo fat harvest and intraarticular injection of a placebo that has been visually matched to the active test substance. All subjects will undergo imaging studies, clinical evaluations, and laboratory testing prior to and after the procedure; patients will be followed for 48 weeks after intraarticular injections are performed.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Celution Device, Placebo
- Keywords
- osteoarthritis, knee, adipose derived regenerative cells, ADRC, Celution, arthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celution DeviceDevice
ADRCs Prepared using the Celution Device
PlaceboOther
Inactive Placebo
| Study group | Role | What they receive |
|---|---|---|
| Celution ADRCs; Low Dose | Experimental | Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 20,000,000 ADRCs per single intraarticular administration Receives: Device: Celution Device |
| Celution ADRCs; High Dose | Experimental | Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs per single intraarticular administration Receives: Device: Celution Device |
| Placebo | Placebo comparator | Sterile Lactated Ringers Solution (5mL) mixed with ≤ 0.20 ml of the study subject's own freshly drawn blood. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain on Walking
Measured: 12 Weeks
Secondary outcomes (8)
Observed Pain Scores on 50-foot Walk Test
Measured: 48 Weeks
Number of Observed OARS130 Responders
Measured: 48 Weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 48 Weeks
VAS Assessments
Measured: 48 Weeks
Patient Global Assessment
Measured: 48 Weeks
Use of Rescue Medication
Measured: 48 Weeks
SF-36 Questionnaire
Measured: 48 Weeks
MRI Osteoarthritis Knee Score
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kesten, MD, Study director, Cytori Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326961
- Sponsor's protocol ID
- ACT-OA Knee
- Acronym
- ACT-OA Knee
- Status last verified
- Oct 2016
- First submitted
- 19 Nov 2014
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee: A Double-blind, Placebo Controlled, Multi-center Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT02326961
- Acronym / sponsor ID
- ACT-OA Knee / ACT-OA Knee
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, adipose derived regenerative cells, ADRC, Celution, arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Dec 2014 (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.
The primary objective of this study is to evaluate the safety and feasibility of intraarticular injection of Celution prepared adipose-derived regenerative cells injected into knees of patients with chronic knee pain due to osteoarthritis.
Detailed description
The ACT - OA Knee Clinical Trial is a prospective, randomized, multi-center device trial intended to assess safety and feasibility of intraarticular administration of Celution processed Adipose Derived Regenerative Cells (ADRCs). The study will include 90 patients in up to 15 sites in the United States.
Subjects that have chronic knee pain due to idiopathic osteoarthritis of the knee (confirmed clinically and radiologically) will be evaluated for eligibility in this study. Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo fat harvest through small volume liposuction under local anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for immediate intraarticular administration. A dose escalation approach has been designed wherein the study is divided into two double-blind, randomized, placebo-controlled parts as follows:
Part A:
Low Dose (20,000,000 cells): 30 patients OR Placebo: 15 patients
Part B:
High Dose (40,000,000 cells): 30 patients OR Placebo: 15 patients
Subjects randomized to placebo will undergo fat harvest and intraarticular injection of a placebo that has been visually matched to the active test substance. All subjects will undergo imaging studies, clinical evaluations, and laboratory testing prior to and after the procedure; patients will be followed for 48 weeks after intraarticular injections are performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Celution ADRCs; Low Dose | Experimental | Device: Celution DeviceAdipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 20,000,000 ADRCs per single intraarticular administration |
| Celution ADRCs; High Dose | Experimental | Device: Celution DeviceAdipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs per single intraarticular administration |
| Placebo | Placebo comparator | Other: PlaceboSterile Lactated Ringers Solution (5mL) mixed with ≤ 0.20 ml of the study subject's own freshly drawn blood. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females ≥ 40 and < 70 years of age
- Able to provide written informed consent
- Diagnosis of osteoarthritis in one or both knees by American College of Rheumatology (ACR) criteria
- Kellgren and Lawrence grade 2 or 3 (standing AP x-ray) of the target knee within the preceding 6 months
- Pain due to osteoarthritis in the target knee ≥ 6 months
Key exclusion criteria (17 listed)
- Any major injury to the target knee within the 12 months prior to the screening visit
- Need for cane or other assistance device for walking
- Any surgery to the target knee within the 6 months prior to the screening visit, or surgery to the contralateral knee or other weight-bearing joint if it will interfere with knee assessments
- Prior articular transplant procedures
- Prior ligament reconstruction to the target knee within 12 months prior to the screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celution DeviceADRCs Prepared using the Celution Device | Device | Celution ADRCs; High Dose, Celution ADRCs; Low Dose |
| PlaceboInactive Placebo | Other | Placebo |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain on Walking
Time frame: 12 Weeks
8 secondary outcomes
Observed Pain Scores on 50-foot Walk Test
Time frame: 48 Weeks
Number of Observed OARS130 Responders
Time frame: 48 Weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 48 Weeks
VAS Assessments
Time frame: 48 Weeks
Patient Global Assessment
Time frame: 48 Weeks
Use of Rescue Medication
Time frame: 48 Weeks
SF-36 Questionnaire
Time frame: 48 Weeks
MRI Osteoarthritis Knee Score
Time frame: 48 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 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, MD study director
Cytori Therapeutics
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celution Device in people with Osteoarthritis, Knee, run by Cytori Therapeutics at 11 sites in United States.
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 11 inclusion and 17 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: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain on Walking (time frame: 12 Weeks). 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 28 Oct 2016.