Cellular Matrix Device for the Treatment of Mild to Moderate Knee Osteoarthritis

NCT03328728 | Unknown

• 1 other identifier: 2015-OA-003
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular Matrix represents a therapeutic advantage to relieve symptoms associated with a mild to moderate knee osteoarthritis (particularly pain on walking) compared to hyaluronic acid only (Synvisc®-One).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline pain on walking (Western Ontario & McMaster Universities [WOMAC] A1 of the WOMAC questionaire) at 6 months

  For each group, pain on walking will be evaluated using a 100-mm Visual Analog Scale (VAS), where 0= no pain and 100 = extreme pain

  6 months

Secondary Outcomes (13)

• Change from Baseline pain on walking at 1 and 3 months

  1 and 3 months

• Change from Baseline overall knee osteoarthritis symptoms at 1, 3 and 6 Months

  1, 3 and 6 months

• Change from Baseline pain at 1, 3 and 6 Months

  1, 3 and 6 months

• Change from Baseline stiffness at 1, 3 and 6 Months

  1, 3 and 6 months

• Change from Baseline physical function at 1, 3 and 6 Months

  1, 3 and 6 months

Study Arms (2)

Cellular Matrix / A-CP HA Kit

EXPERIMENTAL

One intra-articular injection of a combination of PRP and non-crosslinked HA

Device: Cellular Matrix / A-CP HA Kit

Synvisc-One

ACTIVE COMPARATOR

One intra-articular injection of a crosslinked HA

Device: Synvisc-One

Interventions

Cellular Matrix / A-CP HA Kit DEVICE

Treatment with a single intra-articular injection in the knee of Cellular Matrix / A-CP HA Kit; Cellular Matrix / A-CP HA Kit is designed for the safe, rapid and extemporaneous preparation of a cellular matrix of autologous PRP combined with HA. The Cellular Matrix / A-CP HA Kit is a single-use medical device including hematology tubes (A-CP HA tube), designed for blood collection and PRP/HA preparation after 5 min centrifugation. This tube contains a non-crosslinked hyaluronic acid (MW 1550 kDa) solution, a gel acting as a cell separator, and a sodium citrate acting as an anticoagulant. During centrifugation, the separator gel moves to form a barrier that separates red blood cells from other blood components. The HA, which migrates to the top of the gradient during centrifugation, can be mixed with PRP in order to give rise to a ready-to-use PRP/HA preparation.

Cellular Matrix / A-CP HA Kit

Synvisc-One DEVICE

Treatment with a single intra-articular injection in the knee of Synvisc-One; Synvisc-One (hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing hylans. Hylans are derivatives of hyaluronans (sodium salt of hyaluronic acid). Hylan A has an average molecular weight of 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F 20 contains hylan A and hylan B (8.0 mg per ml) in buffered physiological sodium chloride solution.

Synvisc-One

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• femorotibial knee osteoarthritis defined according to the American College of Rheumatology (ACR) criteria
• Symptomatic knee osteoarthritis of a unilateral knee, characterized by pain at walking (WOMAC A1 score assessed over the previous 24 hours on a 100-mm Visual Analog Scale (VAS): 50 ≤ WOMAC A1 ≤ 90) or reduced joint function (total WOMAC C score assessed or over the previous 24 hours on a 100-mm VAS: 50 ≤ WOMAC A1 ≤ 90)
• Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain of 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day
• Radiographic femorotibial knee osteoarthritis (radiograph not older than 3 months) Kellgren \& Lawrence grades of II-III
• Outpatient capable of walking 50 meters without assistance
• Signature of the informed consent form
• Capable of understanding the study's imperatives, as well as written instructions
• Capable of filling-out evaluation questionnaires

You may not qualify if:

• Radiographic femoro-tibial knee osteoarthritis Kellgren \& Lawrence grades of I or IV
• Bilateral knee osteoarthritis, characterized by pain greater than 30 of both knees evaluated on a 0 to 100-mm scale and requiring systemic analgesic treatment or paracetamol greater than 4g/ day
• Viscosupplementation in the past 3 months
• Corticosteroid injection in the past 3 months
• PRP or PRP/HA injection in the past 12 months
• Any surgery of the knee planned during the next 6 months
• Systematic use of corticosteroids (except those that are inhaled) or level III analgesics in the past 3 months and NSAID (non-steroidal anti-inflammatory drugs) during the past month
• Treatment with slow-acting anti-rheumatic drugs (diacerhein, soybean or avocado unsaponifiables, chondroitin sulfate, glucosamine) started in the past 6 months
• History of allergy to hyaluronic acid
• Auto-immune disease (rheumatoid arthritis, lupus)
• Surgery of the affected knee in the past 3 months
• Infection of the affected knee in the past 6 months
• Rheumatologic disorder other than arthritis
• Clinical evidence of local inflammation such as redness or heat of the joint
• Hereditary or acquired hematologic or clotting disorders, such as drepanocytosis, platelet dysfunction, thrombocytopenia (\<150'000 platelets/mm3), etc.

Sponsors & Collaborators

• Regen Lab SA: lead

Study Sites (1)

Clinique Médipôle garonne

Toulouse, Haute-Garonne, 31036, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe Adam, MD

  Clinique Médipôle Garonne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie de Fourmestraux, PhD

CONTACT

+41(0)218640110; vdefourmestraux@regenlab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 1, 2017
• Study Start: July 18, 2017
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

FR (1)