Clinical trial NCT04331327: Intra-articular Injection of Allogenic Lyophilized Growth Factors in Primary Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteo Arthritis Knee
Keywords: osteoarthritis
allogenic platelet rich plasma
lyophilization
growth factors
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline WOMAC scores at 6 months
timeFrame: At baseline and after 6 months.
measure: Change from Baseline structural outcomes scores at 6 months
timeFrame: At baseline and after 6 months.
Secondary outcomes:
measure: post injection complications of the intervention treatment
timeFrame: at each time following the injection
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: rheumatology and clinical immunology unit of internal medicine department of Kasr Al-ainy Hospital, Cairo University
Study officials:
affiliation: Kasr Alainy School of Medicine, Cairo University
name: Kamel Gado, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.