Plasma Rich in Growth Factors (PRGF) Treatment for Muscle Tear

Muscle Tear Clinical Trial

Official title:

PRP as a Treatment for Acute Muscle Tears - Randomized-double-blind-placebo Control Trail.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726245
• Other study ID #: 3000
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 29, 2008
• Last updated: July 10, 2011
• Start date: January 2008
• Est. completion date: March 2011

Study information

• Verified date: July 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• US diagnosed muscle tear

• age 15-40 years old

Exclusion Criteria:

• pregnancy

• mental or physical disabilities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Tear

Intervention

Biological:
• PRGF
3-6mg IM (to area of muscle tear)
• Placebo
3cc IM of physiological saline

Locations

Country	Name	City	State
Israel	Meir Medicak Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of symptoms / disease progress		1 year	Yes