Plasma Rich in Growth Factors (PRGF) Treatment for Muscle... | NCT00726245

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

NCT00726245

Sponsor

Meir Medical Center

Status

Completed

Last Update Posted

Jul 12, 2011Estimated

Enrollment

50Estimated

Phase

Phase 2Phase 3

Conditions

Muscle Tear

Interventions

PRGF
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jul 29, 2008

First Submission Date that Met QC Criteria

Jul 30, 2008

First Posted Date

Jul 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2011

Last Update Posted Date

Jul 12, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	PRGF	Biological: PRGF
2	Placebo Comparator	physiological saline	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRGF	Biological	3-6mg IM (to area of muscle tear)	1
Placebo

Measure	Description	Time Frame
improvement of symptoms / disease progress		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

US diagnosed muscle tear
age 15-40 years old

Exclusion Criteria:

pregnancy
mental or physical disabilities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medicak Center		Kfar Saba			Israel