Outcomes Data of Bone Marrow Stem Cells to Treat Hip and... | NCT01601951

Studies
Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis

NCT01601951

Sponsor

Regenerative Pain Center, Illinois

Status

Completed

Last Update Posted

Mar 18, 2014Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Hip and Knee Osteoarthritis

Interventions

Procedural, Bone Marrow concentrate injection

Countries

United States

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

Mar 2014

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

Apr 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

May 14, 2012

First Submission Date that Met QC Criteria

May 16, 2012

First Posted Date

May 18, 2012Estimated

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

Mar 14, 2014

Last Update Posted Date

Mar 18, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.

Inclusion Criteria:

Subjects must be scheduled for an autologous bone marrow hip or knee injection
Subjects must have a diagnosis of hip or knee osteoarthritis
Subjects must be between the ages of 18 and 85
Subjects must be willing and able to sign Informed Consent
Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
Subjects for whom baseline data is not available

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hip Osteoarthritis			Other: Procedural, Bone Marrow concentrate injection
Knee Osteoarthritis			Other: Procedural, Bone Marrow concentrate injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Procedural, Bone Marrow concentrate injection	Other	This is strictly data collection and outcomes based. The procedure is not part of this study	Hip Osteoarthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Pain Scale	Change in subjective pain measure	Baseline, 6 weeks, 3 months, 1 year
Harris Hip Score or Knee Society Score	Change in subjective pain, function, functional activity measurement and a clinical physical exam	Baeline, 6 weeks, 3 months, 1 year
Physician Global Assessment	Change in physician rated disease activity measurement	Baseline, 6 weeks, 3 months, 1 year

Secondary Outcomes

Measure	Description	Time Frame
Radiologic	Radiographic changes of the hip or knee	Baseline, 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be scheduled for an autologous bone marrow hip or knee injection
Subjects must have a diagnosis of hip or knee osteoarthritis
Subjects must be between the ages of 18 and 85
Subjects must be willing and able to sign Informed Consent
Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
Subjects for whom baseline data is not available

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mitchell Sheinkop, M.D.	Regenerative Pain Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regenerative Pain Center		Des Plaines	Illinois	60016	United States

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided