Lateral EpicondylitisPhase 2NCT03811145
An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis
A Phase 2 study testing Tendoncel in people with Lateral Epicondylitis, run by Cell Therapy Ltd. at 1 site in Greece.
Trial summary
Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication - both steroidal and non-steroidal, and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Tendoncel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- May 2014to Nov 2015
- 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
- Subjects aged 18 years and over and in good general health
- Subjects who have a diagnosis of lateral epicondylitis, Cozen's test
- Subjects who are willing to attend all study assessments and follow-up appointments
- Subjects who are able to understand the study, and are willing to co-operate with the study procedures and restrictions
Who cannot join
- Subjects have been receiving additional concurrent treatment (e.g. surgical or steroid injection) for lateral epicondylitis.
- Subjects who have medial epicondylitis or another condition of the elbow (test side only)
- Subjects who have participated in any clinical study during the previous 30 days of initiation of this study
- Subjects with a history of alcohol, substance or drug abuse in the previous 12 months
- Subjects with any significant concurrent illness
- Subjects with a heart pacemaker
Show all 15Show fewer
- Subjects with diabetes either type I or type II (owing to possible poor wound healing)
- Subjects that have undergone surgery in the past 3 months
- Subjects with any active or significant history of skin disorders at the treatment area(s) e.g. hypo pigmentation (vitiligo)
- Subjects with any inflammatory skin condition (eczema, psoriasis, herpes simplex/complex)
- Subjects with a history (or family history) of skin cancer, skin tumours or any other malignant disease
- Subjects with any irritation, tattoo's, piercings, scars, birthmarks, or heavy presence of freckles at the treatment site(s)
- Subjects currently taking anti-histamine or steroid medication
- Subject who due to impaired mobility would not be able to undertake independent care
- Subjects who are pregnant or who are breast feeding.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou
Thessaloniki, 57010
About this study
Official title: A Double-Blind Randomised Placebo-controlled Phase IIb Clinical Trial to Study the Efficacy & Safety of a Novel Platelet Lysate Gel in the Treatment of Lateral Epicondylitis
Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication - both steroidal and non-steroidal, and surgery. Current experimental therapies include muscle relaxants to reduce muscle tone and force on the epicondyle, laser therapy to stimulate collagen production, and blood based therapies including the injection of autologous blood and protein rich plasma.
Cell Therapy Ltd (trading as Celixir) has developed a regenerative gel that combines isolated allogeneic platelet growth factors and a cellulose-derivative gel.
Read the detailed description
Lateral epicondylitis, also called "tennis elbow" is a common condition affecting 1 to 3% of the population; most commonly individuals aged 35 to 55 years. It is frequently self limiting but can lead to refractory symptoms in a minority of cases. Pain is localised to the lateral epicondyle of the elbow at the point of insertion of the common extensor tendon. Although associated with repetitive movement of the extensor muscles of the forearm, frequently no precipitating cause can be discerned.
The term "epicondylitis" is a misnomer as histological investigations have revealed that there is only limited inflammation, and the term "epicondylosis" should be employed, due to the degenerative nature of the condition.
The condition is divided in to 4 stages, though progression may not occur through all four. Firstly, there is acute inflammation that is quick to resolve. Secondly, prolonged injury results in an increase in fibroblasts, vascular hyperplasia, disorganised collagen disposition and degeneration of the tendon. Thirdly, further accumulation of structural alterations leads to partial or complete tendon rupture. Stage 4 exhibits the same features as 2 and 3 but with the addition of calcification.
Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication both steroidal and non-steroidal, and surgery. Current experimental therapies include muscle relaxants to reduce muscle tone and force on the epicondyle, laser therapy to stimulate collagen production, and blood based therapies including the injection of autologous blood and protein rich plasma. Trials of the latter two treatments give conflicting results due to variations in protocol and trial design.
Cell Therapy Ltd has developed a regenerative gel, Tendoncel, that combines isolated platelet growth factors and cellulose-derivative gel. Tendoncel consists of a proprietary platelet lysate formulation that is easy to apply to the skin.
- Conditions
- Lateral Epicondylitis
- Being tested
- Tendoncel, Placebo control gel
- Keywords
- Topical, Gel, Platelet, Growth factor, Regenerative
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TendoncelBiological
Platelet lysate gel
Placebo control gelOther
Placebo control gel
| Study group | Role | What they receive |
|---|---|---|
| Tendoncel | Experimental | Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days. Receives: Biological: Tendoncel |
| Placebo control gel | Placebo comparator | Placebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days. Receives: Other: Placebo control gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Measured: Baseline
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Measured: Day 23 (end of treatment).
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Measured: 4 weeks follow up
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Measured: 6 weeks follow up.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Measured: 3 months follow up.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Measured: Mean of 47 weeks follow up.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Measured: Baseline
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Measured: Day 23.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Measured: 4 week follow up.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Measured: 6 week follow up.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Measured: 3 months follow up
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Measured: Mean of 47 weeks follow up.
Pain free grip strength
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Measured: Baseline
Pain free grip strength
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Measured: Day 23
Pain free grip strength
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Measured: Mean of 47 weeks follow up (final follow up).
Secondary outcomes (5)
Safety - Number of participants in each group with adverse events.
Measured by participant questionnaire. Comparison of the number of participants in each group with cutaneous events - "redness", "rash", "swelling" or changes at gel site. Classed as none, mild, moderate or severe. Plus any other event mentioned by the participants.
Measured: Day 3 (1st treatment visit), day 7, day 14, day 21, day 23 (end of treatment). Follow ups: 4 weeks, 6 weeks, 3 months and mean of 47 weeks.
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
Measured: Baseline
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
Measured: Day 7
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
Measured: Day 23
Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.
Measurement of blood IgE levels. Comparison of the number of participants in each group, test and control, with a normal baseline reading of blood IgE and a subsequently elevated IgE reading. Normal is <100IU/mL.
Measured: Baseline, day 7 and day 23.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
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 Lateral EpicondylitisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell Therapy Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- George Papanicolaou Hospital
- Responsible party
- Sponsor
- Investigators
- Givissis Panagiotis, MD, Principal investigator, Aristotle University of Thessaloniki, General Hospital of Papanikolaou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811145
- Sponsor's protocol ID
- CTL/LE/01/0514
- Status last verified
- Dec 2019
- First submitted
- 16 Jan 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.
PubMed 23997125
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomised Placebo-controlled Phase IIb Clinical Trial to Study the Efficacy & Safety of a Novel Platelet Lysate Gel in the Treatment of Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT03811145
- Acronym / sponsor ID
- CTL/LE/01/0514
- Conditions
- Lateral Epicondylitis
- Keywords
- Topical, Gel, Platelet, Growth factor, Regenerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cell Therapy Ltd.Industry (pharma, biotech, devices)
- Collaborators
- George Papanicolaou Hospital
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Jan 2019 (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.
Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication - both steroidal and non-steroidal, and surgery. Current experimental therapies include muscle relaxants to reduce muscle tone and force on the epicondyle, laser therapy to stimulate collagen production, and blood based therapies including the injection of autologous blood and protein rich plasma.
Cell Therapy Ltd (trading as Celixir) has developed a regenerative gel that combines isolated allogeneic platelet growth factors and a cellulose-derivative gel.
Detailed description
Lateral epicondylitis, also called "tennis elbow" is a common condition affecting 1 to 3% of the population; most commonly individuals aged 35 to 55 years. It is frequently self limiting but can lead to refractory symptoms in a minority of cases. Pain is localised to the lateral epicondyle of the elbow at the point of insertion of the common extensor tendon. Although associated with repetitive movement of the extensor muscles of the forearm, frequently no precipitating cause can be discerned.
The term "epicondylitis" is a misnomer as histological investigations have revealed that there is only limited inflammation, and the term "epicondylosis" should be employed, due to the degenerative nature of the condition.
The condition is divided in to 4 stages, though progression may not occur through all four. Firstly, there is acute inflammation that is quick to resolve. Secondly, prolonged injury results in an increase in fibroblasts, vascular hyperplasia, disorganised collagen disposition and degeneration of the tendon. Thirdly, further accumulation of structural alterations leads to partial or complete tendon rupture. Stage 4 exhibits the same features as 2 and 3 but with the addition of calcification.
Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication both steroidal and non-steroidal, and surgery. Current experimental therapies include muscle relaxants to reduce muscle tone and force on the epicondyle, laser therapy to stimulate collagen production, and blood based therapies including the injection of autologous blood and protein rich plasma. Trials of the latter two treatments give conflicting results due to variations in protocol and trial design.
Cell Therapy Ltd has developed a regenerative gel, Tendoncel, that combines isolated platelet growth factors and cellulose-derivative gel. Tendoncel consists of a proprietary platelet lysate formulation that is easy to apply to the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tendoncel | Experimental | Biological: TendoncelTopically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days. |
| Placebo control gel | Placebo comparator | Other: Placebo control gelPlacebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 18 years and over and in good general health
- Subjects who have a diagnosis of lateral epicondylitis, Cozen's test
- Subjects who are willing to attend all study assessments and follow-up appointments
- Subjects who are able to understand the study, and are willing to co-operate with the study procedures and restrictions
Key exclusion criteria (15 listed)
- Subjects have been receiving additional concurrent treatment (e.g. surgical or steroid injection) for lateral epicondylitis.
- Subjects who have medial epicondylitis or another condition of the elbow (test side only)
- Subjects who have participated in any clinical study during the previous 30 days of initiation of this study
- Subjects with a history of alcohol, substance or drug abuse in the previous 12 months
- Subjects with any significant concurrent illness
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 |
|---|---|---|
| TendoncelPlatelet lysate gel | Biological | Tendoncel |
| Placebo control gelPlacebo control gel | Other | Placebo control gel |
Primary outcome
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Time frame: Baseline
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Time frame: Day 23 (end of treatment).
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Time frame: 4 weeks follow up
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Time frame: 6 weeks follow up.
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Time frame: 3 months follow up.
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Time frame: Mean of 47 weeks follow up.
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Baseline
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Day 23.
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: 4 week follow up.
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: 6 week follow up.
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: 3 months follow up
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Mean of 47 weeks follow up.
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Pain free grip strength
Time frame: Baseline
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Pain free grip strength
Time frame: Day 23
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Pain free grip strength
Time frame: Mean of 47 weeks follow up (final follow up).
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
5 secondary outcomes
Safety - Number of participants in each group with adverse events.
Time frame: Day 3 (1st treatment visit), day 7, day 14, day 21, day 23 (end of treatment). Follow ups: 4 weeks, 6 weeks, 3 months and mean of 47 weeks.
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Time frame: Baseline
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Time frame: Day 7
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Time frame: Day 23
Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.
Time frame: Baseline, day 7 and day 23.
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 12 Dec 2019.
- Background: PubMed 23997125Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.
- Ahmad et al., (2013)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Givissis Panagiotis, MD principal investigator
Aristotle University of Thessaloniki, General Hospital of Papanikolaou
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 Tendoncel in people with Lateral Epicondylitis, run by Cell Therapy Ltd. at 1 site in Greece.
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 4 inclusion and 15 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 12 Dec 2019. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire (time frame: Baseline). The study lists 15 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 NCT03811145, 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 12 Dec 2019.