PainPhase 1/2NCT02210468
APIC-CF Therapy for Mild to Moderate Osteoarthritis of the Knee
A Phase 1/2 study testing APIC-CF, 4 cc and APIC-CF, 2 cc in people with Pain and Osteoarthritis, run by Cytonics Corporation at 1 site in United States.
Trial summary
The mechanism of Osteoarthritis (OA) is complex, however the investigators know that cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes, leading to proteases that break down cartilage. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- APIC-CF, 4 cc and APIC-CF, 2 cc
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2016
- Phase
- Phase 1/2
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient provides signed written informed consent
- The patient is willing and able to complete effectiveness and safety questionnaires and is able to read and understand study instructions in English.
- Patient is a male or female aged between 21 - 70 years of age at the time of informed consent.
- Patient is ambulatory (assistive devices allowed if used 4 weeks or more prior to Screening).
- Patient has symptomatic OA in the target knee
- Patient has a radiographic confirmation of OA at the target knee prior to screening with a grade II or III score on the K-L grading scale (Kellgren, 1957)using radiographs performed within 24 weeks of Screening
- The patient has knee pain as demonstrated by a score of ≤3 on the KOOS pain subscale
- The patient has venous access sufficient for APIC-CF production
Who cannot join
- The patient has any of the following:
- Grade 4 score on the K-L grading scale for the target knee
- Grade 3 score on the K-L grading scale and exhibits at least one Grade 4 characteristic (large osteophytes, marked narrowing of joint space, severe sclerosis, or definite deformity of bone contour).
- Acute fracture of the lower limb.
- Medical history of severe bone disease (e.g., osteoporosis, osteonecrosis, joint deformity, instability, or septic arthritis).
- The patient is categorized as grossly obese, defined as body mass index (BMI) greater than 35 kg/m2
Show all 38Show fewer
- Hemoglobin values <11 g/dL
- Pregnant or breastfeeding women
- Has clinically apparent tense effusion of the target knee.
- Has had chondrocyte transplantation or reconstruction of ligaments in the target knee.
- Has received an intra-articular injection(s) into any joint (e.g., corticosteroids or chondroprotective agents) within 60 days prior to Screening. Subjects receiving a corticosteroid injection during the study will be withdrawn from the study.
- Has had surgery to the target knee within 12 months or arthroscopy of the target knee within 90 days prior to Screening.
- Has an inflammatory disease of either knee other than OA (e.g., rheumatoid arthri septic arthritis).
- Has another disease that can affect the health of the knee (e.g., chronic hemochromatosis; sickle cell anemia; arthropathies of systemic diseases such as chondrocalcinosis, gout, pseudogout, psoriasis, hemophilia, and infectious diseases of the joints).
- Has significant joint infection in the target knee or inflammatory or skin disorder in the injection area of the target knee.
- Septic arthritis in any joints within 1 year prior to screening;
- Has fibromyalgia, anserine bursitis, lumbar radiculopathy, neurogenic or vascular claudication, vascular insufficiency of lower limbs, or peripheral neuropathy severe enough to interfere with the study evaluations.
- Patella femoral instability
- Patients with a history of cartilage allograft, autograft or microfracture in the study knee
- Patients with a history of any type of blood coagulation or bleeding disorder, currently taking warfarin or other parental anticoagulant therapy or history of DVT/PE during <1 year of Screening.
- Has a systemic or other disease or significant liver function test result from screening that, in the opinion of the investigator, would interfere with study evaluation or have an impact on the balance of benefits and risks of study treatment.
- Diseases that may interfere:
- type 1 diabetes
- immunodeficiency syndrome
- significant cardiovascular, renal, or liver disease
- severe anemia
- severe thrombocytopenia
- severe infectious disease with or without fever.
- any significant chronic skin disorders, active skin or soft tissue infection that could interfere with the evaluation of the injection site.
- mal-alignment/deformity of the leg
- active asthma that may require periodic treatment with steroids during the study period
- active malignancy receiving treatment, or prior history of any malignancy, with the exception of basal cell carcinoma of the skin treated more than 1 year ago
- Patients with psychiatric or neurological disorders including cognitive impairment or inability to provide informed consent
- Incarcerated or confined patients
- Medical-legal, personal injury, ongoing litigation or worker's compensation claim
- History of drug abuse
- Use of investigational drug, device, or biologic within 12 weeks of screening
- Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
IRC Clinical
Townsend, Maryland, 21204
Kendra Barton, RN, BSN, 443-275-1599, kendra.barton@ircclinical.com
About this study
Official title: A Phase I/II, Multicenter, Double-Blind, Placebo-controlled Safety and Efficacy Study to Evaluate APIC-CF Therapy for Mild to Moderate Primary Osteoarthritis of the Knee
The mechanism of Osteoarthritis (OA) is complex, however the investigators know that cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes, leading to proteases that break down cartilage. There is a protein in the human blood called alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage. Cytonics developed a device that use the patient's own blood to remove all cells and concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.
- Conditions
- Pain, Osteoarthritis
- Being tested
- APIC-CF, 4 cc, APIC-CF, 2 cc, Placebo Comparator: Saline
- Keywords
- Osteoarthritis, Protease Inhibitors, Alpha-2-macroglobulin, Autologous treatment, APIC-CF, Pain due to Mild to Moderate osteoarthritis (OA) of the knee
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APIC-CF, 4 ccDevice
APIC-CF, 2 ccDevice
Placebo Comparator: SalineOther
Placebo Comparator: Saline
| Study group | Role | What they receive |
|---|---|---|
| APIC-CF 4cc, | Experimental | APIC-CF 4cc, once at first day Receives: Device: APIC-CF, 4 cc |
| APIC-CF, 2cc | Experimental | APIC-CF, 2cc, one at first day Receives: Device: APIC-CF, 2 cc |
| Saline | Placebo comparator | Not described Receives: Other: Placebo Comparator: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain after 8 weeks
Statistically significant reduction in pain after 8 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Measured: 8 weeks
Reduction in pain while walking at 8 weeks
Statistically significant reduction in pain while walking after 8 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Measured: 8 weeks
Secondary outcomes (4)
Reduction in pain after 2 weeks
Statistically significant reduction in pain after 2 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score.
Measured: 2 weeks
Reduction in pain while walking at 2 weeks
Statistically significant reduction in pain while walking after 2 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Measured: 2 weeks
Reduction in pain at 24 weeks
Statistically significant reduction in pain after 24 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Measured: 24 weeks
Reduction in pain while walking after 24 weeks
Statistically significant reduction in pain while walking after 24 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startMay 2015
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytonics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210468
- Sponsor's protocol ID
- Cyt300-01
- Status last verified
- Aug 2015
- First submitted
- 23 Jul 2014
- Last updated
- 21 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multicenter, Double-Blind, Placebo-controlled Safety and Efficacy Study to Evaluate APIC-CF Therapy for Mild to Moderate Primary Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02210468
- Acronym / sponsor ID
- Cyt300-01
- Conditions
- Pain, Osteoarthritis
- Keywords
- Osteoarthritis, Protease Inhibitors, Alpha-2-macroglobulin, Autologous treatment, APIC-CF, Pain due to Mild to Moderate osteoarthritis (OA) of the knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cytonics CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Aug 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 mechanism of Osteoarthritis (OA) is complex, however the investigators know that cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes, leading to proteases that break down cartilage. There is a protein in the human blood called alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage. Cytonics developed a device that use the patient's own blood to remove all cells and concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APIC-CF 4cc, | Experimental | Device: APIC-CF, 4 ccAPIC-CF 4cc, once at first day |
| APIC-CF, 2cc | Experimental | Device: APIC-CF, 2 ccAPIC-CF, 2cc, one at first day |
| Saline | Placebo comparator | Other: Placebo Comparator: Saline |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient provides signed written informed consent
- The patient is willing and able to complete effectiveness and safety questionnaires and is able to read and understand study instructions in English.
- Patient is a male or female aged between 21 - 70 years of age at the time of informed consent.
- Patient is ambulatory (assistive devices allowed if used 4 weeks or more prior to Screening).
- Patient has symptomatic OA in the target knee
Key exclusion criteria (38 listed)
- The patient has any of the following:
- Medical history of severe bone disease (e.g., osteoporosis, osteonecrosis, joint deformity, instability, or septic arthritis).
- The patient is categorized as grossly obese, defined as body mass index (BMI) greater than 35 kg/m2
- Hemoglobin values <11 g/dL
- Pregnant or breastfeeding women
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 |
|---|---|---|
| APIC-CF, 4 cc | Device | APIC-CF 4cc, |
| APIC-CF, 2 cc | Device | APIC-CF, 2cc |
| Placebo Comparator: SalinePlacebo Comparator: Saline | Other | Saline |
Primary outcome
Reduction in pain after 8 weeks
Time frame: 8 weeks
Statistically significant reduction in pain after 8 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Reduction in pain while walking at 8 weeks
Time frame: 8 weeks
Statistically significant reduction in pain while walking after 8 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
4 secondary outcomes
Reduction in pain after 2 weeks
Time frame: 2 weeks
Reduction in pain while walking at 2 weeks
Time frame: 2 weeks
Reduction in pain at 24 weeks
Time frame: 24 weeks
Reduction in pain while walking after 24 weeks
Time frame: 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APIC-CF, 4 cc and APIC-CF, 2 cc in people with Pain and Osteoarthritis, run by Cytonics Corporation at 1 site 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 8 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Scuderi, MD (561-575-4451 ext. 1, scuderimd@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain after 8 weeks (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 21 Aug 2015.