Intra-articular Injection of Allogenic Lyophilized Growth Factors in Primary Knee Osteoarthritis

Clinical and Ultrasonographic Assessment of Effectiveness of Intra-articular Knee Injection Using Platelet Derived Lyophilized Growth Factors in Egyptian Patients With Symptomatic Primary Knee Osteoarthritis

the study was conducted on 31-patients with symptomatic primary knee osteoarthritis. The patients were randomized into intervention and control groups. The control group was kept on their medications without intervention. The intervention group received two doses of allogenic lyophilized growth factors (L-GFs); at baseline and after 2 months.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Drug: allogenic lyophilized growth factors

Detailed Description

the study included 31 patients with symptomatic primary knee osteoarthritis (KOA) The study group was randomized into an intervention group and a control one. The control group patients were kept on their traditional medications without any intervention, while intervention group patients were instructed to stop using non-steroidal anti-inflammatory drugs (NSAID) at least 1 week before the assessment and throughout the study. All participants were subjected to baseline clinical, radiographic, and ultrasonography assessment. Follow up assessments was conducted after 6 months.

Patients of the intervention group received two doses of intra-articular knee injections of allogenic lyophilized growth factors (L-GFs); one dose at the baseline and the other was after 2 months.

Lyophilized GFs were prepared at the Cairo Medical Centre Blood Bank from allogenic platelet rich plasma to according a previously published patented method.

Prior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. Then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration.

The injection was done under complete guidance of ultrasonography through lateral supra-patellar short axis in-plane approach under sterile aseptic conditions. After injection, local ice application and oral paracetamol were allowed if the patient felt pain. NSAIDs were completely avoided as they may inhibit the desired post-injection inflammatory process. Patients were encouraged to restrict vigorous knee activities for 48 hours.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • rheumatology and clinical immunology unit of internal medicine department of Kasr Al-ainy Hospital, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Clinical and radiographic diagnosis of primary knee osteoarthritis
• Patients must be symptomatic

Exclusion Criteria:

• Patients with secondary knee osteoarthritis
• previous intra-articular steroid, or hyaluronic knee injection in last year
• Patients with other disabling lower limb osteoarthropathy or myopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Allogenic lyophilized growth factors; Two doses of intra-articular knee injections of lyophilized growth factors were received one dose at the baseline and the other was after 2 months.	Drug: allogenic lyophilized growth factors; Prior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. Then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration.
No Intervention: Standard of care; The patients were kept on their traditional medications without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline WOMAC scores at 6 months	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores consist of 24 questions in 3 sections regarding; five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A sum of the scores for all three sub-scales gives a total WOMAC score. The higher scores mean a worse outcome.	At baseline and after 6 months.
Change from Baseline structural outcomes scores at 6 months	Knee ultrasonography assessment of effusion, femoral cartilage, anterior horn medial meniscus, synovial hypertrophy	At baseline and after 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post injection complications of the intervention treatment	The patients of the intervention group were asked if they experienced any adverse events following the injection, with special concern on: Post-injection pain: Both the duration and intensity were documented. The pain intensity was measured by 0-10 visual analogue scale (VAS).; General symptoms or signs related to infection and allergy such as fever, chills, pruritus, dyspnea, urticaria, or rash.; Erythema, swelling, or abnormal discharge from the site of injection.	at each time following the injection

Collaborators and Investigators

• Sponsor: Rasmia Elgohary
• Investigators: Principal Investigator: Kamel Gado, MD, Kasr Alainy School of Medicine, Cairo University

Publications and helpful links

General Publications

• El-Gohary R, Diab A, El-Gendy H, Fahmy H, Gado KH. Using intra-articular allogenic lyophilized growth factors in primary knee osteoarthritis: a randomized pilot study. Regen Med. 2021 Feb;16(2):113-115. doi: 10.2217/rme-2020-0104. Epub 2021 Mar 23.

Helpful Links

• A patent method describing the preparation of lyophilized growth factors from allogenic platelet rich plasma

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): April 28, 2018
• Study Completion (Actual): April 28, 2018

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; allogenic platelet rich plasma; lyophilization; growth factors
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 1/2016-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study protocol and statistical analysis plan
• IPD Sharing Time Frame: after publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No