Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Hip

Who is this study for? Adult patients with Osteoarthritis
What treatments are being studied? StroMed Autologous Regenerative Cell Therapy
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000 patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.

• Patients range from 18-90 years of age.

• Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.

• Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.

• Patients with adequate cardiac and respiratory function.

• Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT

• Patients must have adequate immune system function, with no known immunodeficiency disease.

• Greater than 6 months hip pain with the index side (left or right).

Locations
United States
Pennsylvania
VivaTech International, Inc.
RECRUITING
Grove City
Contact Information
Primary
Scott M Herkes, MBA
scott.herkes@gmail.com
855-984-8287
Backup
Michael P Hutchinson, DVM
drmike@vivatechusa.com
412-503-3788
Time Frame
Start Date: 2015-07
Estimated Completion Date: 2026-08
Participants
Target number of participants: 4000
Treatments
Experimental: StroMed + Platelet Rich plasma [PRP]
Because no enzymes or drugs are added with this mechanical process, the resulting (StroMed) cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Additional treatments with Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product by direct injection to affected joints.
Related Therapeutic Areas
Sponsors
Leads: VivaTech International, Inc.

This content was sourced from clinicaltrials.gov

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