Osteo Arthritis KneePhase 2NCT04331327
Intra-articular Injection of Allogenic Lyophilized Growth Factors in Primary Knee Osteoarthritis
A Phase 2 study testing allogenic lyophilized growth factors in people with Osteo Arthritis Knee, run by Rasmia Elgohary at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- allogenic lyophilized growth factors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to 28 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiographic diagnosis of primary knee osteoarthritis
- Patients must be symptomatic
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
rheumatology and clinical immunology unit of internal medicine department of Kasr Al-ainy Hospital, Cairo University
Cairo, 11562
About this study
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
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.
Read the 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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- allogenic lyophilized growth factors
- Keywords
- osteoarthritis, allogenic platelet rich plasma, lyophilization, growth factors
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogenic lyophilized growth factorsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: allogenic lyophilized growth factors |
| Standard of care | No intervention | The patients were kept on their traditional medications without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At baseline and after 6 months.
Secondary outcomes (1)
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.
Measured: at each time following the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 May 2017
- Primary completion28 Apr 2018
- Study completion28 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rasmia Elgohary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rasmia Elgohary, Cairo University
- Investigators
- Kamel Gado, MD, Principal investigator, Kasr Alainy School of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331327
- Sponsor's protocol ID
- 1/2016-2017
- Status last verified
- Jan 2021
- First submitted
- 27 Mar 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and statistical analysis plan
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.
PubMed 33754800
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04331327
- Acronym / sponsor ID
- 1/2016-2017
- Conditions
- Osteo Arthritis Knee
- Keywords
- osteoarthritis, allogenic platelet rich plasma, lyophilization, growth factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rasmia ElgoharyUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 28 Apr 2018 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogenic lyophilized growth factors | Active comparator | Drug: allogenic lyophilized growth factorsTwo doses of intra-articular knee injections of lyophilized growth factors were received one dose at the baseline and the other was after 2 months. |
| Standard of care | No intervention | –The patients were kept on their traditional medications without any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical and radiographic diagnosis of primary knee osteoarthritis
- Patients must be symptomatic
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogenic lyophilized growth factorsPrior 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. | Drug | Allogenic lyophilized growth factors |
Primary outcome
Change from Baseline WOMAC scores at 6 months
Time frame: At baseline and after 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.
Change from Baseline structural outcomes scores at 6 months
Time frame: At baseline and after 6 months.
Knee ultrasonography assessment of effusion, femoral cartilage, anterior horn medial meniscus, synovial hypertrophy
1 secondary outcome
post injection complications of the intervention treatment
Time frame: at each time following the injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Derived from this study: PubMed 33754800El-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.
- A patent method describing the preparation of lyophilized growth factors from allogenic platelet rich plasmaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. study protocol and statistical analysis plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamel Gado, MD principal investigator
Kasr Alainy School of Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allogenic lyophilized growth factors in people with Osteo Arthritis Knee, run by Rasmia Elgohary at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline WOMAC scores at 6 months (time frame: At baseline and after 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04331327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.