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

Rheumatoid Arthritis Clinical Trial

Official title:

Outcomes of Single Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Pain in the Lumbar Facet Joints, Sacroiliac Joints, Upper Extremity Joints, and Lower Extremity Joints

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01978639
• Other study ID #: APS 2013-022
• Secondary ID: 2013-022
• Status: Active, not recruiting
• Phase: N/A
• First received: November 1, 2013
• Last updated: May 23, 2017
• Start date: January 2014

Study information

• Verified date: May 2017
• Source: Arizona Pain Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

1. A single injection of Applied Biologics' FloGraftTM.

2. A single injection of autologous bone marrow derived stem cells.

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Arizona Pain Specialists	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona Pain Specialists

Country where clinical trial is conducted

United States, 

References & Publications (7)

Díaz-Prado S, Rendal-Vázquez ME, Muiños-López E, Hermida-Gómez T, Rodríguez-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. — View Citation

Filardo G, Kon E, Buda R, Timoncini A, Di Martino A, Cenacchi A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular knee injections for the treatment of degenerative cartilage lesions and osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2011 Apr;19(4):528-35. doi: 10.1007/s00167-010-1238-6. Epub 2010 Aug 26. — View Citation

Lee KB, Hui JH, Song IC, Ardany L, Lee EH. Injectable mesenchymal stem cell therapy for large cartilage defects--a porcine model. Stem Cells. 2007 Nov;25(11):2964-71. Epub 2007 Jul 26. — View Citation

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. Review. — View Citation

Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. — View Citation

Sampson S, Reed M, Silvers H, Meng M, Mandelbaum B. Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Am J Phys Med Rehabil. 2010 Dec;89(12):961-9. doi: 10.1097/PHM.0b013e3181fc7edf. — View Citation

Wakitani S, Imoto K, Yamamoto T, Saito M, Murata N, Yoneda M. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. 2002 Mar;10(3):199-206. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oswestry Disability Index	Total score from the Oswestry Disability Index	24 week follow up
Secondary	SF-36	Total score from the SF-36	24 week follow up
Secondary	Pain Medications survey	Reduction in reported pain medication usage.	24 week follow up
Secondary	Global Pain Scale	Levels of pain, emotional health, quality of life, and activities of daily living.	24 week follow up
Secondary	Adverse Events	Any adverse events between the study procedure and the 24 week follow up will be assessed.	24 week follow up