Influence of Plasma Rich in Growth Factors (PRGF) on Heal... | NCT00743886

Studies
Influence of Plasma Rich in Growth Factors (PRGF) on Healing of Medial Collateral Ligament (MCL) Tear

NCT00743886

Sponsor

Meir Medical Center

Status

Withdrawn

Last Update Posted

Jul 12, 2011Estimated

Enrollment

50Estimated

Phase

Phase 2Phase 3

Conditions

MCL Tear

Interventions

Plasma Rich in Growth Factors (PRGF)
saline

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

Withdrawn

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 2009Actual

First Submitted Date

Aug 28, 2008

First Submission Date that Met QC Criteria

Aug 28, 2008

First Posted Date

Aug 29, 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

Description Module

Brief Summary

To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of medial collateral ligament (MCL) tear.

Detailed Description

Autologous platelet-rich matrices may aid in the healing of ligaments & tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

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
2	Placebo Comparator	saline	Drug: saline
1	Experimental	Plasma Rich in Growth Factors (PRGF)	Biological: Plasma Rich in Growth Factors (PRGF)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasma Rich in Growth Factors (PRGF)	Biological	injection onto injured area in ligament dose: 3-6mg	1

Measure	Description	Time Frame
time and efficiency of healing		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-40 years old
diagnosed MCL tear grade 2/3

Exclusion Criteria:

pregnancy
mental or physical disabilities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omer Mei Dan, Dr	Meir Medical Center	Principal Investigator

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
D036341	Intercellular Signaling Peptides and Proteins
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

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Browse Branches

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