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

Phase 2

Recruiting

• Conditions: Osteoarthritis
• Interventions: Biological: [StroMed + platelet rich plasma (PRP)]

• Registration Number: NCT02844738
• Lead Sponsor: VivaTech International, Inc.

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

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
StroMed + platelet rich plasma (PRP)	[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 Measures

Name	Time	Method
Change is being assessed for the DASH Survey (Disabilities of the Arm, Shoulder, Hand	0,2,6 months	Disabilities of the Arm, Shoulder, and Hand

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VivaTech International, Inc.; 🇺🇸 Grove City, Pennsylvania, United States