- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00726245
Plasma Rich in Growth Factors (PRGF) Treatment for Muscle Tear
July 10, 2011 updated by: Meir Medical Center
PRP as a Treatment for Acute Muscle Tears - Randomized-double-blind-placebo Control Trail.
the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kfar Saba, Israel
- Meir Medicak Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 40 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- US diagnosed muscle tear
- age 15-40 years old
Exclusion Criteria:
- pregnancy
- mental or physical disabilities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
PRGF
|
3-6mg IM (to area of muscle tear)
|
|
PLACEBO_COMPARATOR: 2
physiological saline
|
3cc IM of physiological saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
improvement of symptoms / disease progress
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
February 1, 2009
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
July 29, 2008
First Submitted That Met QC Criteria
July 30, 2008
First Posted (ESTIMATE)
July 31, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 12, 2011
Last Update Submitted That Met QC Criteria
July 10, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 3000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscle Tear
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Cytori TherapeuticsWithdrawn
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Recruiting
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Groupe Hospitalier Paris Saint JosephActive, not recruitingObstetric Complications | Muscle TearFrance
-
Hand Therapy BarcelonaRecruitingSplints | Hand Injuries | Muscle TearSpain
-
Cytori TherapeuticsWithdrawn
-
University GhentResearch Foundation FlandersRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Anterior Cruciate Ligament Reconstruction | ACL | ACL Injury | ACL Tear | Arthrogenic Muscle Inhibition | Arthrogenic Muscle ResponsesBelgium
-
AspetarNot yet recruitingMuscle Tear | Hamstring Muscles | Hamstring Muscle Repair | Hamstring Rupture | Hamstring InjuriesQatar
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Robert WestermannWithdrawnMuscle Atrophy | ACL Tear | Quadriceps Muscle Atrophy | Muscle Atrophy, ProximalUnited States
-
Sahlgrenska University HospitalGöteborg University; Vastra Gotaland Region; The Swedish Society of MedicineRecruitingMuscle Weakness | Muscle Atrophy | Arthroplasty Complications | Muscle TearSweden
-
Smith & Nephew, Inc.CompletedMeniscal Tear | Meniscus TearUnited States
Clinical Trials on PRGF
-
Ain Shams UniversityCompletedAlveolar Socket Preservations
-
Universidad de GranadaBTI Biotechnology InstituteCompleted
-
Fundación Eduardo AnituaCompleted
-
Clinica Oftalmologica ParedesCompletedMacular Holes | Macular Hole of Left Eye (Disorder) | Macular Hole of Right Eye (Disorder)Colombia
-
University of Roma La SapienzaUniversidade da Coruña; NYU College of DentistryUnknownOsteonecrosis Due to Drugs, Jaw
-
Queen Mary University of LondonRecruiting
-
Biotechnology Institute IMASDWithdrawnAndrogenetic AlopeciaSpain
-
IVI BilbaobTI VitoriaCompletedVascular Endothelial Growth Factor OverexpressionSpain
-
Clinica Universidad de Navarra, Universidad de...Unknown
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Meir Medical CenterWithdrawnPartial Supraspinatus TearIsrael