Muscle LesionsPhase 2NCT01381770
Platelet-derived Factors for Treatment of Muscular Lesions
A Phase 2 study testing platelet-derived repairing factors in people with Muscle Lesions, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Lesions
- What is being tested?
- platelet-derived repairing factors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2010to May 2013
- 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
- age > 18 years old
- if woman, no pregnancy ongoing
- muscular lesion grade 2 or 3 in a lower limb muscular group
Who cannot join
- no hematological conditions
- no anticoagulation in the two preceding weeks
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
About this study
Official title: Platelet-derived Factors for Treatment of Muscular Lesions: a Phase II Trial
The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25.
- Conditions
- Muscle Lesions
- Being tested
- platelet-derived repairing factors
- Keywords
- muscular lesions grade 2, muscular lesions grade 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet-derived repairing factorsBiological
autologous platelet lysate injection within 24 hours from lesion
| Study group | Role | What they receive |
|---|---|---|
| Platelet-derived repairing factors | Experimental | Not described Receives: Biological: platelet-derived repairing factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury.
If the athlete is able, 21 days after the muscular injury, to return to (at least) training activities, the outcome will be coded "successful"; and "unsuccessful" otherwise
Measured: 21 days from enrollment
Secondary outcomes (5)
Time-to-return to sport activities
Measured: within 4 months from lesion
Side effects
Overall frequency of patients with any adverse events (number, proportion and 95%CI)
Measured: within 4 months from treatment
time-to-healing at ultrasound
Measured: within 4 months from treatment
side effects
types of side effects (number, proportion and 95%CI for each type of adverse events)
Measured: within 4 months from treatment
side effects
grade of side effects (number, proportion and 95%CI for each grade of adverse events)
Measured: within 4 months from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LesionsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Pavesi, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381770
- Sponsor's protocol ID
- plt-msl001
- Status last verified
- Aug 2015
- First submitted
- 23 Jun 2011
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-derived Factors for Treatment of Muscular Lesions: a Phase II Trial
- ClinicalTrials.gov ID
- NCT01381770
- Acronym / sponsor ID
- plt-msl001
- Conditions
- Muscle Lesions
- Keywords
- muscular lesions grade 2, muscular lesions grade 3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Jun 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.
The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet-derived repairing factors | Experimental | Biological: platelet-derived repairing factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years old
- if woman, no pregnancy ongoing
- muscular lesion grade 2 or 3 in a lower limb muscular group
Key exclusion criteria (2 listed)
- no hematological conditions
- no anticoagulation in the two preceding weeks
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 |
|---|---|---|
| platelet-derived repairing factorsautologous platelet lysate injection within 24 hours from lesion | Biological | Platelet-derived repairing factors |
Primary outcome
number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury.
Time frame: 21 days from enrollment
If the athlete is able, 21 days after the muscular injury, to return to (at least) training activities, the outcome will be coded "successful"; and "unsuccessful" otherwise
5 secondary outcomes
Time-to-return to sport activities
Time frame: within 4 months from lesion
Side effects
Time frame: within 4 months from treatment
time-to-healing at ultrasound
Time frame: within 4 months from treatment
side effects
Time frame: within 4 months from treatment
side effects
Time frame: within 4 months from treatment
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 25 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 platelet-derived repairing factors in people with Muscle Lesions, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 2 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 25 Aug 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 Italy. 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?
number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury. (time frame: 21 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2015.