APIC-CF Therapy for Mild to Moderate Osteoarthritis of the Knee
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
1 other identifier
interventional
300
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pain
Started May 2015
Typical duration for phase_1 pain
1 active site
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
First Submitted
Initial submission to the registry
July 23, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 21, 2015
August 1, 2015
1.2 years
July 23, 2014
August 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
8 weeks
Secondary Outcomes (4)
Reduction in pain after 2 weeks
2 weeks
Reduction in pain while walking at 2 weeks
2 weeks
Reduction in pain at 24 weeks
24 weeks
Reduction in pain while walking after 24 weeks
24 week
Study Arms (3)
APIC-CF 4cc,
EXPERIMENTALAPIC-CF 4cc, once at first day
APIC-CF, 2cc
EXPERIMENTALAPIC-CF, 2cc, one at first day
Saline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRC Clinical
Townsend, Maryland, 21204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2014
First Posted
August 6, 2014
Study Start
May 1, 2015
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
August 21, 2015
Record last verified: 2015-08