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

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.
ClinicalTrials.gov Identifier: NCT00726245
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Meir Medical Center

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

Condition or disease Intervention/treatment Phase
Muscle Tear Biological: PRGF Biological: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP as a Treatment for Acute Muscle Tears - Randomized-double-blind-placebo Control Trail.
Study Start Date : January 2008
Primary Completion Date : February 2009
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. improvement of symptoms / disease progress [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • mental or physical disabilities

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): NCT00726245


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

Responsible Party: Omer Mei-Dan, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00726245     History of Changes
Other Study ID Numbers: 3000
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011