Trial Outcomes & Findings for Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA) (NCT NCT01773226)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Up to 6 months post-injection

Results posted on

2018-02-05

Participant Flow

Single-centre study in the Netherlands. FPI April 2013.

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

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Protein Solution "APS(TM)" n=11 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	57 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Netherlands	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months post-injection

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Autologous Protein Solution "APS(TM)" n=11 Participants 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
Number of Adverse Events	22 Adverse Events (AEs)

SECONDARY outcome

Timeframe: Up to 6 months post-injection

Population: The incidence of patients using rescue medication for OA pain.

Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee.

Outcome measures

Outcome measures
Measure	Autologous Protein Solution "APS(TM)" n=11 Participants 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
Number of Patients Using Rescue Medication Injection visit	2 Frequency of Patients using Rescue medic
Number of Patients Using Rescue Medication Month 6	2 Frequency of Patients using Rescue medic

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, and at Months 1, 3, and 6.

Population: Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.

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.

Outcome measures

Outcome measures
Measure	Autologous Protein Solution "APS(TM)" n=11 Participants 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
Pain Score Baseline	12 Scores on a WOMAC pain scale Standard Deviation 1.6
Pain Score Week 1	8.2 Scores on a WOMAC pain scale Standard Deviation 5.1
Pain Score Week 2	6.5 Scores on a WOMAC pain scale Standard Deviation 4.7
Pain Score Month 1	4.5 Scores on a WOMAC pain scale Standard Deviation 4.1
Pain Score Month 3	3.0 Scores on a WOMAC pain scale Standard Deviation 3.1
Pain Score Month 6	3.1 Scores on a WOMAC pain scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, and at Months 1, 3, and 6.

Population: Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.

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.

Outcome measures

Outcome measures
Measure	Autologous Protein Solution "APS(TM)" n=11 Participants 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
Stiffness Score Baseline	4.9 Scores on a WOMAC stiffness scale Standard Deviation 0.9
Stiffness Score Week 1	3.8 Scores on a WOMAC stiffness scale Standard Deviation 1.7
Stiffness Score Week 2	3.1 Scores on a WOMAC stiffness scale Standard Deviation 1.2
Stiffness Score Month 1	2.5 Scores on a WOMAC stiffness scale Standard Deviation 1.8
Stiffness Score Month 3	1.7 Scores on a WOMAC stiffness scale Standard Deviation 1.8
Stiffness Score Month 6	2.3 Scores on a WOMAC stiffness scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, and at Months 1, 3, and 6.

Population: Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.

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.

Outcome measures

Outcome measures
Measure	Autologous Protein Solution "APS(TM)" n=11 Participants 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
Physical Function Score Baseline	38.1 Scores on a WOMAC functionality scale Standard Deviation 7.5
Physical Function Score Week 1	27.8 Scores on a WOMAC functionality scale Standard Deviation 16.2
Physical Function Score Week 2	21.9 Scores on a WOMAC functionality scale Standard Deviation 13.4
Physical Function Score Month 1	17.5 Scores on a WOMAC functionality scale Standard Deviation 15.1
Physical Function Score Month 3	10 Scores on a WOMAC functionality scale Standard Deviation 11.4
Physical Function Score Month 6	12.3 Scores on a WOMAC functionality scale Standard Deviation 14.7

Adverse Events

Autologous Protein Solution "APS(TM)"

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Autologous Protein Solution "APS(TM)" n=11 participants at risk 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
Musculoskeletal and connective tissue disorders Joint effusion	54.5% 6/11 • Number of events 7 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	27.3% 3/11 • Number of events 4 • 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.
Musculoskeletal and connective tissue disorders Joint stiffness	27.3% 3/11 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders Joint instability	18.2% 2/11 • Number of events 2 • 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.
General disorders Fatigue	9.1% 1/11 • Number of events 1 • 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.
General disorders Site Discomfort	9.1% 1/11 • Number of events 1 • 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.
General disorders Injection site joint pain	9.1% 1/11 • Number of events 1 • 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.
General disorders Malaise	9.1% 1/11 • Number of events 1 • 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.
Gastrointestinal disorders Tootache	9.1% 1/11 • Number of events 1 • 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.
Injury, poisoning and procedural complications Procedural Nausea	9.1% 1/11 • Number of events 1 • 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.

Additional Information

Linda Korthout, Scientific Affairs Specialist

Zimmer Biomet

Phone: +31.610.072.853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60