Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Shoulder

Part of paid clinical trials in Grove City, Pennsylvania.

Sponsor
VivaTech International, Inc.
Study ID
NCT02844738
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • [StroMed + platelet rich plasma (PRP)] — BIOLOGICAL
    Patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit and Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints at the time of initial treatment. Thereafter the affected joints will be treated as direct injections to the joint with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product. Day 0 \[StroMed + platelet rich plasma (PRP)\], Days 7 and 14 \[PRP\]

Study Details

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 shoulder. Follow-up will consist of a larger sample including 4,000 patients.

Key Dates

Start date
Jul 31, 2015
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
4,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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 processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to affected joint.

Primary Outcome Measure

Change is being assessed for the DASH Survey (Disabilities of the Arm, Shoulder, Hand [ Time Frame: 0,2,6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VivaTech International, Inc.Grove CityPennsylvania16127
Scott M Herkes, MBA
[email protected]
855-984-8287
Michael Hutchinson, DVM
[email protected]
412-503-3788
Mark LoDico, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Grove City, PA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
VivaTech International, Inc.· Grove City, PA

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