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This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Protein Solution "APS(TM)" | Experimental | Patients who have been treated with a single, intra-articular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Protein Solution "APS(TM)" | Device | A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months. | Up to 6 months post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Using Rescue Medication | Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee. | Up to 6 months post-injection |
| Pain Score | The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. |
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Eligibility Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R.A.M. van Drumpt, M.D. | St. Anna Hospital, Geldrop, NL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Anna Hospital | Geldrop | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26915009 | Derived | King W, van der Weegen W, Van Drumpt R, Soons H, Toler K, Woodell-May J. White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution. J Exp Orthop. 2016 Dec;3(1):9. doi: 10.1186/s40634-016-0043-7. Epub 2016 Feb 9. |
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All patients treated with APS who had at least 1 post-injection assessment of clinical outcomes were to be included in the clinical outcomes population, which was used for the clinical outcomes summaries and listings
Single-centre study in the Netherlands. FPI April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Protein Solution "APS(TM)" | Patients who have been treated with a single, intra-articular injection. Autologous Protein Solution "APS(TM)": A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Protein Solution "APS(TM)" | Patients who have been treated with a single, intra-articular injection. Autologous Protein Solution "APS(TM)": A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events | Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months. | In cases where a patient reported multiple occurrences of an AE, the first occurrence of the worst reported case of the event was to be used for the purpose of analysis. | Posted | Number | Adverse Events (AEs) | Up to 6 months post-injection |
|
AEs were recorded at each visit (Week 1, Week 2, Month 1, Month 3, Month 6)
In cases where a patient reported multiple occurrences of an AE, the first occurrence of the worst reported case of the event was to be used for the purpose of analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autologous Protein Solution "APS(TM)" | Patients who have been treated with a single, intra-articular injection. Autologous Protein Solution "APS(TM)": A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA® version 16.1 | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Korthout, Scientific Affairs Specialist | Zimmer Biomet | +31.610.072.853 | Linda.Korthout.external@zimmerbiomet.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Baseline, Week 1, Week 2, and at Months 1, 3, and 6. |
| Stiffness Score | Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. | Baseline, Week 1, Week 2, and at Months 1, 3, and 6. |
| Physical Function Score | Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. | Baseline, Week 1, Week 2, and at Months 1, 3, and 6. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Number of Patients Using Rescue Medication | Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee. | The incidence of patients using rescue medication for OA pain. | Posted | Number | Frequency of Patients using Rescue medic | Up to 6 months post-injection |
|
|
|
| Secondary | Pain Score | The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. | Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint. | Posted | Mean | Standard Deviation | Scores on a WOMAC pain scale | Baseline, Week 1, Week 2, and at Months 1, 3, and 6. |
|
|
|
| Secondary | Stiffness Score | Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. | Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint. | Posted | Mean | Standard Deviation | Scores on a WOMAC stiffness scale | Baseline, Week 1, Week 2, and at Months 1, 3, and 6. |
|
|
|
| Secondary | Physical Function Score | Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation. | Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint. | Posted | Mean | Standard Deviation | Scores on a WOMAC functionality scale | Baseline, Week 1, Week 2, and at Months 1, 3, and 6. |
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|
| 0 |
| 11 |
| 9 |
| 11 |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA® version 16.1 | Systematic Assessment |
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| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA® version 16.1 | Systematic Assessment |
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| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA® version 16.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA® version 16.1 | Systematic Assessment |
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| Site Discomfort | General disorders | MedDRA® version 16.1 | Systematic Assessment |
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| Injection site joint pain | General disorders | MedDRA® version 16.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA® version 16.1 | Systematic Assessment |
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| Tootache | Gastrointestinal disorders | MedDRA® version 16.1 | Systematic Assessment |
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| Procedural Nausea | Injury, poisoning and procedural complications | MedDRA® version 16.1 | Systematic Assessment |
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