Platelet-derived Factors for Treatment of Muscular Lesions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by IRCCS Policlinico S. Matteo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01381770
First received: June 23, 2011
Last updated: June 24, 2011
Last verified: January 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: within 4 months from treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: within 4 months from treatment ] [ Designated as safety issue: Yes ]
    types of side effects (number, proportion and 95%CI for each type of adverse events)

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


Estimated Enrollment: 25
Study Start Date: September 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381770

Contacts
Contact: Claudio Pavesi, MD +39 382 502854 claudiopavesi@tiscali.it

Locations
Italy
Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Claudio Pavesi, MD    +39 382 502854    claudiopavesi@tiscali.it   
Principal Investigator: Claudio Pavesi, MD         
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
  More Information

No publications provided

Responsible Party: Claudio Pavesi, Fondazione IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01381770     History of Changes
Other Study ID Numbers: plt-msl001
Study First Received: June 23, 2011
Last Updated: June 24, 2011
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014