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

NCT04331327 | Completed Phase 2

• 1 other identifier: 1/2016-2017
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

osteoarthritis; allogenic platelet rich plasma; lyophilization; growth factors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• post injection complications of the intervention treatment

  at each time following the injection

Study Arms (2)

Allogenic lyophilized growth factors

ACTIVE COMPARATOR

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

Standard of care

NO INTERVENTION

The patients were kept on their traditional medications without any intervention

Interventions

allogenic lyophilized growth factors DRUG

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.

Allogenic lyophilized growth factors

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rasmia Elgohary: lead

Study Sites (1)

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

Cairo, 11562, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33754800 DERIVED

Related Links

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

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kamel Gado, MD

  Kasr Alainy School of Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of internal medicine, subspecialty rheumatology and clinical immunology

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: May 1, 2017
• Primary Completion: April 28, 2018
• Study Completion: April 28, 2018
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication

Locations

EG (1)