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

This study has been completed.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00726245
First received: July 29, 2008
Last updated: July 10, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Muscle Tear
 Biological: PRGF
Biological: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP as a Treatment for Acute Muscle Tears - Randomized-double-blind-placebo Control Trail.

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • improvement of symptoms / disease progress [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2008
Study Completion Date: March 2011
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PRGF
 Biological: PRGF
3-6mg IM (to area of muscle tear)
Placebo Comparator: 2
physiological saline
 Biological: Placebo
3cc IM of physiological saline

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • US diagnosed muscle tear
  • age 15-40 years old

Exclusion Criteria:

  • pregnancy
  • mental or physical disabilities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726245

Locations
Israel
Meir Medicak Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Omer Mei-Dan, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00726245     History of Changes
Other Study ID Numbers: 3000
Study First Received: July 29, 2008
Last Updated: July 10, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

ClinicalTrials.gov processed this record on May 21, 2013