Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I)

NCT02262364 | Completed Phase 1 Results DMC

• 1 other identifier: APSS-22-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the safety of a single injection of APS.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Adverse Events and Serious Adverse Events

  1 Year

Secondary Outcomes (3)

• Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire

  12 months

• Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)

  12 months

• Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)

  12 months

Study Arms (1)

NStride APS

EXPERIMENTAL

Subjects will receive an intra-articular injection of APS.

Biological: APS

Interventions

APS BIOLOGICAL

See above

NStride APS

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥40 and ≤75 years old at time of injection..
• A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 (within 6 months of screening).
• Body mass index ≤40 kg/m2.
• A Western Ontario and McMaster Universities osteoarthritis index using the Likert scale, Version 3. (WOMAC LK 3.1) pain subscale total score ≥ 10 and ≤ 19.
• Has undergone at least two prior conservative OA therapies without satisfactory pain relief.
• Patient has failed to get satisfactory pain relief from either HA or steroid injections or would be considered an appropriate patient to receive either HA or steroid injections

You may not qualify if:

• Presence of active infection or abnormal effusion in the knee immediately preceding treatment injection.
• Presence of symptomatic OA in the non-study knee
• Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases, or of metabolic origin; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, villonodular synovitis, and other non-OA joint disease.
• Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the index knee
• Untreated symptomatic injury of index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, meniscus injury, cartilage lesion).
• Knee radiographs showing bone-on-bone or other gross cartilage deficits.
• Presence of surgical hardware or other foreign body in the index knee.
• Intra-articular steroid injections in the index knee within 3 months of screening.
• Intra-articular HA in the index knee within 6 months of screening.
• Other intra-articular therapy in the index knee within 6 months prior to screening.
• Systemic steroid use within 2 weeks of screening.
• Planned/anticipated surgery of the index knee during the study period.
• A history of local anesthetic allergy
• Use of systemic immunosuppressants within six weeks of treatment.
• Currently on anticoagulant therapy

Sponsors & Collaborators

• Zimmer Biomet: lead
• Biomet Biologics, LLC: collaborator

Study Sites (1)

Orthopedic and Sports Medicine Center of Northern Indiana (OSMC)

Elkhart, Indiana, 46550, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Jennifer Woodell-May, PhD
• Organization: Zimmer Biomet

jennifer.woodell-may@zimmerbiomet.com

Study Officials

• Mark Klaassen

  OSMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: October 13, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-10

Locations

US (1)