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

Rasmia Elgohary

Status and phase: Completed; Phase 2

Conditions: Osteo Arthritis Knee

Treatments: Drug: allogenic lyophilized growth factors

Study type: Interventional

Funder types: Other

Identifiers

NCT04331327

1/2016-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Allogenic lyophilized growth factors

Active Comparator group

Description:

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.

Treatment:

Drug: allogenic lyophilized growth factors

Standard of care

No Intervention group

Description:

The patients were kept on their traditional medications without any intervention