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

August 4, 2023 updated by: VivaTech International, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Patients will be treated for Osteoarthritis (OA) of the shoulder due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Patient outcomes will be tracked with laboratory tests for inflammation markers, the DASH and SPADI questionnaires and a follow up MRI at various endpoints to 6 months. SF-36 forms (a quality of life measure) and numerical ratings scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending shoulder planning/replacement therapy.

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Grove City, Pennsylvania, United States, 16127
        • Recruiting
        • VivaTech International, Inc.
        • Principal Investigator:
          • Mark LoDico, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
  2. Patients range from 18-90 years of age.
  3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
  4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
  5. Patients with adequate cardiac and respiratory function.
  6. Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT
  7. Patients must have adequate immune system function, with no known immunodeficiency disease.
  8. Greater than 6 months shoulder pain with the index side (left or right shoulder).

Exclusion Criteria:

  1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
  2. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke)..
  3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.
  4. Patients infected with hepatitis B, C or HIV.
  5. Patients with Body Mass Index (BMI) > 40kg/m2
  6. Presence of active infection.
  7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.

  8. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:

    1. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis
    2. Corticosteroid injection at treatment site within 1 month
    3. Consistent use of NSAIDs within 48 hours of procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: [StroMed + platelet rich plasma (PRP)]
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]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change is being assessed for the DASH Survey (Disabilities of the Arm, Shoulder, Hand
Time Frame: 0,2,6 months
Disabilities of the Arm, Shoulder, and Hand
0,2,6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change is being assessed by MRI of afflicted joint
Time Frame: 0 and (6 months optional)
Looking for cartilage regrowth via MRI
0 and (6 months optional)
Change is being assessed for the SPADI Survey (Shoulder Pain and Disability Index)
Time Frame: 0,2,6 Months
Shoulder Pain and Disability Index
0,2,6 Months
Change is being assessed for the SF36 Survey (Short Form Health Survey)
Time Frame: 0,2,6 Months
Short Form Health Survey
0,2,6 Months
Change is being assessed for the NRS Survey (Numerical Rating Scale for Pain)
Time Frame: 0,2,6 Months
Numerical Rating Scale for Pain
0,2,6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VivaTech International, Inc.

Investigators

  • Principal Investigator: Mark LoDico, MD, Advanced Regenerative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimated)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  •  IRCM-2016-113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

VivaTech will monitor data and decide if/when data can be shared

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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