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

Primary Purpose

Osteoarthritis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[StroMed + platelet rich plasma (PRP)]

[PRP] platelet rich plasma

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, grade 2 or more. 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 knee pain on the index side (left or right knee).

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 and 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. Knee instability.
2. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery.
3. Gout or pseudo gout
4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis
5. Corticosteroid injection at treatment site within 1 month
6. Consistent use of NSAIDs within 48 hours of procedure.

Sites / Locations

VivaTech International, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Interventions assigned by Principal Investigator

Outcomes

Primary Outcome Measures

Change is being assessed for the KOOS survey (Knee Osteoarthritis Outcome Score)

Knee osteoarthritis outcome score

Secondary Outcome Measures

Change is being assessed by MRI of afflicted joint

Looking for cartilage regrowth via MRI

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

NCT02844751

First Posted

July 8, 2016

Last Updated

August 4, 2023

Sponsor

VivaTech International, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02844751

Brief Title

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

Official Title

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

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 knee. Follow-up will consist of a larger sample including 4,000 patients. Patients will be treated for Osteoarthritis (OA) of the knee 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 RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Cohort 1 will include PRP treatments at time of initial StroMed treatment plus at 1 week, 2 weeks and 1 month. Cohort 2 will include PRP treatments at time of initial StroMed treatment plus at 1 month and 2 months. Patient outcomes will be tracked with a follow up MRI at various endpoints to 6 months, laboratory tests for inflammation markers, and knee injury and osteoarthritis outcome score (KOOS) questionnaires. SF-36 forms (a quality of life measure) and numerical rating 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 knee 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

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Interventions assigned by Principal Investigator

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Interventions assigned by Principal Investigator

Intervention Type

Biological

Intervention Name(s)

[StroMed + platelet rich plasma (PRP)]

Intervention Description

[Day 0] - Because no enzymes or drugs are added with this mechanical process, the resulting 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. Also Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint.

Intervention Type

Biological

Intervention Name(s)

[PRP] platelet rich plasma

Intervention Description

Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 7,14 and 30

Intervention Type

Biological

Intervention Name(s)

[PRP] platelet rich plasma

Intervention Description

Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 30 and 60

Primary Outcome Measure Information:

Title

Change is being assessed for the KOOS survey (Knee Osteoarthritis Outcome Score)

Description

Knee osteoarthritis outcome score

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 - 12 months optional)

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, grade 2 or more. 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 knee pain on the index side (left or right knee). 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 and 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: Knee instability. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery. Gout or pseudo gout Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee 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 P 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

website for VivaTech

Learn more about this trial

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

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