Platelet-derived Factors for Treatment of Muscular Lesions

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.

Study Overview

• Status: Completed
• Conditions: Muscle Lesions
• Intervention / Treatment: Biological: platelet-derived repairing factors

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-derived repairing factors	Biological: platelet-derived repairing factors; autologous platelet lysate injection within 24 hours from lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	21 days from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-return to sport activities		within 4 months from lesion
Side effects	Overall frequency of patients with any adverse events (number, proportion and 95%CI)	within 4 months from treatment
time-to-healing at ultrasound		within 4 months from treatment
side effects	types of side effects (number, proportion and 95%CI for each type of adverse events)	within 4 months from treatment
side effects	grade of side effects (number, proportion and 95%CI for each grade of adverse events)	within 4 months from treatment

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: muscular lesions grade 2; muscular lesions grade 3
• Other Study ID Numbers: plt-msl001