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

Primary Purpose

Osteoarthritis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[StroMed + platelet rich plasma (PRP)]

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 shoulder pain with the index side (left or right shoulder).

Exclusion Criteria:

Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke)..
Diagnosis of a transient ischemic attack in the 6 months prior to screening.
Patients infected with hepatitis B, C or HIV.
Patients with Body Mass Index (BMI) > 40kg/m2
Presence of active infection.
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.
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.

Sites / Locations

VivaTech International, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

StroMed + platelet rich plasma (PRP)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change is being assessed for the DASH Survey (Disabilities of the Arm, Shoulder, Hand

Disabilities of the Arm, Shoulder, and Hand

Secondary Outcome Measures

Change is being assessed by MRI of afflicted joint

Looking for cartilage regrowth via MRI

Change is being assessed for the SPADI Survey (Shoulder Pain and Disability Index)

Shoulder Pain and Disability Index

Change is being assessed for the SF36 Survey (Short Form Health Survey)

Short Form Health Survey

Change is being assessed for the NRS Survey (Numerical Rating Scale for Pain)

Numerical Rating Scale for Pain

Full Information

NCT ID

NCT02844738

First Posted

July 8, 2016

Last Updated

August 4, 2023

Sponsor

VivaTech International, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02844738

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 2015 (undefined)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VivaTech International, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

StroMed + platelet rich plasma (PRP)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

[StroMed + platelet rich plasma (PRP)]

Intervention Description

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]

Primary Outcome Measure Information:

Title

Change is being assessed for the DASH Survey (Disabilities of the Arm, Shoulder, Hand

Description

Disabilities of the Arm, Shoulder, and Hand

Time Frame

0,2,6 months

Secondary Outcome Measure Information:

Title

Change is being assessed by MRI of afflicted joint

Description

Looking for cartilage regrowth via MRI

Time Frame

0 and (6 months optional)

Title

Change is being assessed for the SPADI Survey (Shoulder Pain and Disability Index)

Description

Shoulder Pain and Disability Index

Time Frame

0,2,6 Months

Title

Change is being assessed for the SF36 Survey (Short Form Health Survey)

Description

Short Form Health Survey

Time Frame

0,2,6 Months

Title

Change is being assessed for the NRS Survey (Numerical Rating Scale for Pain)

Description

Numerical Rating Scale for Pain

Time Frame

0,2,6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 shoulder pain with the index side (left or right shoulder). Exclusion Criteria: Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke).. Diagnosis of a transient ischemic attack in the 6 months prior to screening. Patients infected with hepatitis B, C or HIV. Patients with Body Mass Index (BMI) > 40kg/m2 Presence of active infection. 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. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to: Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis Corticosteroid injection at treatment site within 1 month Consistent use of NSAIDs within 48 hours of procedure.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Scott M Herkes, MBA

Phone

855-984-8287

scott.herkes@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Michael P Hutchinson, DVM

Phone

412-503-3788

drmike@vivatechusa.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark LoDico, MD

Organizational Affiliation

Advanced Regenerative Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

VivaTech International, Inc.

City

Grove City

State/Province

Pennsylvania

ZIP/Postal Code

16127

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Scott M Herkes, MBA

Phone

855-984-8287

scott.herkes@gmail.com

First Name & Middle Initial & Last Name & Degree

Michael Hutchinson, DVM

Phone

412-503-3788

drmike@vivatechusa.com

First Name & Middle Initial & Last Name & Degree

Mark LoDico, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Links:

URL

http://www.vivatechusa.com

Description

Company Website

Learn more about this trial

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

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