TendinopathyPhase 2/3ATINCT01343836
Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy
A Phase 2/3 study testing Autologous Tenocyte Implantation and Saline in people with Tendinopathy and Achilles Tendon Injury, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study is designed to compare the treatment of 2 groups in patients with Achilles tendinopathy: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tendinopathy, Achilles Tendon Injury, Achillodynia
- What is being tested?
- Autologous Tenocyte Implantation and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2011to Jun 2014
- Phase
- Phase 2/3
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion")
- Symptoms > 2 months
- Age 18-55 years
Who cannot join
- Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
- Condition of the Achilles tendon caused by medications such as quinolones and statins
- Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis.
- Antibiotics allergy (aminoglycoside group)
- A condition that prevents the patients from executing an active rehabilitation programme
- Patient has received an injection for this injury
Show all 11Show fewer
- Patient has received surgical intervention for this injury
- Patient has already one site (left or right) included in this study
- Patient does not wish, for whatever reason, to undergo one of the two treatments
- Known pregnancy
- Nursing women
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Sports medicine department Medical Center The Hague
Leidschendam, South Holland, 2262 BA
About this study
Official title: The Value of Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy: a Double-blind Randomised Clinical Trial
This study is designed to compare the treatment of 2 groups in patients with Achilles tendinopathy: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises
Read the detailed description
Overuse injury of the Achilles tendon is a common entity. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment. Recent studies described new treatment strategies in tendinopathies, such as the use autologous Tenocyte Implantation (ATI). This treatment option can participate actively in tissue repair processes on cell level. The only published clinical pilot study in tendon research reported 60% improvement in all scores after 6 months follow-up.
- Conditions
- Tendinopathy, Achilles Tendon Injury, Achillodynia
- Being tested
- Autologous Tenocyte Implantation, Saline
- Keywords
- autologous tenocytes, cell therapy, eccentric exercises
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Tenocyte ImplantationOther
Intratendinous ATI (autologous tenocyte injection) with eccentric exercises
SalineOther
Intratendinous saline injection with eccentric exercises
| Study group | Role | What they receive |
|---|---|---|
| Autologous Tenocyte Implantation | Experimental | Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises Receives: Other: Autologous Tenocyte Implantation |
| Saline injection | Placebo comparator | Intratendinous saline injection with eccentric exercises Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-A score
a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy
Measured: 24 weeks
Secondary outcomes (3)
Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC)
UTC provides quantitative information on tendon fiber alignment and the related ultra-structural integrity of the tendon tissue through a non-invasive approach and is used in several clinical trials in humans
Measured: 24 weeks
Subjective patient satisfaction
Patient satisfaction will be determined by asking the patient how satisfied he/she is with the effect of the treatment in 4 possible categories: excellent / good / moderate / poor. The groups "excellent" and "good" will be regarded as successful and the groups of "moderate" and "poor" as not successful.
Measured: 24 weeks
Returning to sports level
The patient will be asked whether they are able to return to their sports level. It is a subdivision in 5 groups: A. No sports; B. No return in sports; C. Returning in sports but not in desired sport; D. Returning in desired sport, but not yet old level; E. Returning to old level in desired sport.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2014
- Study completionJun 2014
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 TendinopathyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof J.A.N. Verhaar, Erasmus Medical Center
- Investigators
- J.A.N. Verhaar, Prof, Principal investigator, Erasmus Medical CenterP.L.J. van Veldhoven, MD, Principal investigator, Medical Center The Hague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343836
- Sponsor's protocol ID
- METC10-102
- Acronym
- ATI
- Status last verified
- Feb 2015
- First submitted
- 27 Apr 2011
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen J, Yu Q, Wu B, Lin Z, Pavlos NJ, Xu J, Ouyang H, Wang A, Zheng MH. Autologous tenocyte therapy for experimental Achilles tendinopathy in a rabbit model. Tissue Eng Part A. 2011 Aug;17(15-16):2037-48. doi: 10.1089/ten.TEA.2010.0492. Epub 2011 Jun 10.
PubMed 21495863
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy: a Double-blind Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01343836
- Acronym / sponsor ID
- ATI / METC10-102
- Conditions
- Tendinopathy, Achilles Tendon Injury, Achillodynia
- Keywords
- autologous tenocytes, cell therapy, eccentric exercises
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Apr 2011 (estimated)
- 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.
This study is designed to compare the treatment of 2 groups in patients with Achilles tendinopathy: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises
Detailed description
Overuse injury of the Achilles tendon is a common entity. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment. Recent studies described new treatment strategies in tendinopathies, such as the use autologous Tenocyte Implantation (ATI). This treatment option can participate actively in tissue repair processes on cell level. The only published clinical pilot study in tendon research reported 60% improvement in all scores after 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Tenocyte Implantation | Experimental | Other: Autologous Tenocyte ImplantationIntratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises |
| Saline injection | Placebo comparator | Other: SalineIntratendinous saline injection with eccentric exercises |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion")
- Symptoms > 2 months
- Age 18-55 years
Key exclusion criteria (11 listed)
- Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
- Condition of the Achilles tendon caused by medications such as quinolones and statins
- Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis.
- Antibiotics allergy (aminoglycoside group)
- A condition that prevents the patients from executing an active rehabilitation programme
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 |
|---|---|---|
| Autologous Tenocyte ImplantationIntratendinous ATI (autologous tenocyte injection) with eccentric exercises | Other | Autologous Tenocyte Implantation |
| SalineIntratendinous saline injection with eccentric exercises | Other | Saline injection |
Primary outcome
VISA-A score
Time frame: 24 weeks
a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy
3 secondary outcomes
Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC)
Time frame: 24 weeks
Subjective patient satisfaction
Time frame: 24 weeks
Returning to sports level
Time frame: 24 weeks
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 16 Feb 2015.
- Background: PubMed 21495863Chen J, Yu Q, Wu B, Lin Z, Pavlos NJ, Xu J, Ouyang H, Wang A, Zheng MH. Autologous tenocyte therapy for experimental Achilles tendinopathy in a rabbit model. Tissue Eng Part A. 2011 Aug;17(15-16):2037-48. doi: 10.1089/ten.TEA.2010.0492. Epub 2011 Jun 10.
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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.
J.A.N. Verhaar, Prof principal investigator
Erasmus Medical Center
P.L.J. van Veldhoven, MD principal investigator
Medical Center The Hague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous Tenocyte Implantation and Saline in people with Tendinopathy and Achilles Tendon Injury, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 inclusion and 11 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 16 Feb 2015. 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 Netherlands. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
VISA-A score (time frame: 24 weeks). 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 NCT01343836, 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 16 Feb 2015.