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Platelet-derived Factors for Treatment of Muscular Lesions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381770
First Posted: June 27, 2011
Last Update Posted: August 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Claudio Pavesi, IRCCS Policlinico S. Matteo
  Purpose
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.

Condition Intervention Phase
Muscle Lesions Biological: platelet-derived repairing factors Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Platelet-derived Factors for Treatment of Muscular Lesions: a Phase II Trial

Further study details as provided by Claudio Pavesi, IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Time-to-return to sport activities [ Time Frame: within 4 months from lesion ]
  • Side effects [ Time Frame: within 4 months from treatment ]
    Overall frequency of patients with any adverse events (number, proportion and 95%CI)

  • time-to-healing at ultrasound [ Time Frame: within 4 months from treatment ]
  • side effects [ Time Frame: within 4 months from treatment ]
    types of side effects (number, proportion and 95%CI for each type of adverse events)

  • side effects [ Time Frame: within 4 months from treatment ]
    grade of side effects (number, proportion and 95%CI for each grade of adverse events)


Enrollment: 25
Study Start Date: September 2010
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Platelet-derived repairing factors Biological: platelet-derived repairing factors
autologous platelet lysate injection within 24 hours from lesion

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years old
  • if woman, no pregnancy ongoing
  • muscular lesion grade 2 or 3 in a lower limb muscular group

Exclusion Criteria:

  • no hematological conditions
  • no anticoagulation in the two preceding weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381770


Locations
Italy
Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
  More Information

Responsible Party: Claudio Pavesi, MD, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01381770     History of Changes
Other Study ID Numbers: plt-msl001
First Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by Claudio Pavesi, IRCCS Policlinico S. Matteo:
muscular lesions grade 2
muscular lesions grade 3