Injections of FloGraft Therapy, Autologous Stem Cells, or... | NCT01978639

Studies
Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain

NCT01978639

Sponsor

Arizona Pain Specialists

Status

Unknown status

Last Update Posted

May 25, 2017Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Osteoarthritis
Rheumatoid Arthritis

Interventions

Not provided

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

ID	Type	Description	Link
2013-022	Other Identifier	Scottsdale Healthcare IRB

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2017Estimated

Completion Date

Not provided

First Submitted Date

Nov 1, 2013

First Submission Date that Met QC Criteria

Nov 6, 2013

First Posted Date

Nov 7, 2013Estimated

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

May 23, 2017

Last Update Posted Date

May 25, 2017Actual

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

This study will assess the outcomes of three currently available regenerative treatments (FloGraft, autologous stem cell therapy, platelet rich plasma therapy) for painful degenerative conditions of the joints. Patients receiving one these treatments will be assessed before the treatment procedure and followed up at four points over the six months after their procedure. Patients' pain, quality of life, and pain medication use at follow up will be compared to baseline levels. The investigators hypothesize that all three treatments will be effective in reducing pain, improving quality of life, and reducing pain medication usage.

Detailed Description

This is an open-label, non-randomized study assessing the efficacy of three potentially regenerative treatments for degenerative conditions of the joints of the lower back (facet, sacroiliac), upper extremities (e.g., shoulder), and lower extremities (e.g., hip, knee). These treatments are:

A single injection of Applied Biologics' FloGraftTM.
A single injection of autologous bone marrow derived stem cells.
A single injection of platelet rich plasma.

Subjects will be assessed prior to treatment for their level of pain, quality of life, and pain medication usage. Subjects will be followed up at 4 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment. At each of these follow up visits, pain, quality of life, and pain medication usage will be assessed.

The investigators hypothesize that all three treatment groups will experience reduced pain, improved quality of life, and reduced pain medication usage at follow up.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numerical Pain Rating Scale	Worst pain in the past 24 hours, from 0 (no pain) to 10 (pain as bad as you can imagine).	24 week follow up

Secondary Outcomes

Measure	Description	Time Frame
Oswestry Disability Index	Total score from the Oswestry Disability Index	24 week follow up
SF-36	Total score from the SF-36	24 week follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older,
Ability to complete follow-up visits,
Able to understand the study protocol and provide consent,
Significant pain (average pain in the past month greater than or equal to 5, from 0-10),
Pain lasting at least 3 months,
Pain associated with one of the following conditions: lumbar facet degeneration, - OR -degenerative condition causing upper extremity joint pain, - OR - degenerative condition causing lower extremity joint pain.

Exclusion Criteria:

Current litigation or worker's compensation claim,
Unstable pain medication dosage,
Previous surgery at the affected site,
Injections at the affected site within the past 6 months,
Uncontrolled psychiatric condition,
Pregnancy or lactating in women,
History of adverse reactions to local anesthetic

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults age 18 or older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tory McJunkin, MD	Arizona Pain Specialists	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Pain Specialists		Scottsdale	Arizona	85258	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19130405	Background	Mobasheri A, Csaki C, Clutterbuck AL, Rahmanzadeh M, Shakibaei M. Mesenchymal stem cells in connective tissue engineering and regenerative medicine: applications in cartilage repair and osteoarthritis therapy. Histol Histopathol. 2009 Mar;24(3):347-66. doi: 10.14670/HH-24.347.
20386989	Background	Diaz-Prado S, Rendal-Vazquez ME, Muinos-Lopez E, Hermida-Gomez T, Rodriguez-Cabarcos M, Fuentes-Boquete I, de Toro FJ, Blanco FJ. Potential use of the human amniotic membrane as a scaffold in human articular cartilage repair. Cell Tissue Bank. 2010 May;11(2):183-95. doi: 10.1007/s10561-009-9144-1. Epub 2010 Apr 13.

ID	Term
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid

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