Recruiting NCT02844738

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

Phase II Interventional Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: [StroMed + platelet rich plasma (PRP)].
Who it may be relevant to: Registry conditions: Osteoarthritis. Basic parameters: 18 years — 90 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

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 \[PRP\]

Primary outcome measures

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

Secondary outcome measures (4)

Change is being assessed by MRI of afflicted joint [Time frame: 0 and (6 months optional)]
Change is being assessed for the SPADI Survey (Shoulder Pain and Disability Index) [Time frame: 0,2,6 Months]
Change is being assessed for the SF36 Survey (Short Form Health Survey) [Time frame: 0,2,6 Months]
Change is being assessed for the NRS Survey (Numerical Rating Scale for Pain) [Time frame: 0,2,6 Months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 1 center

VivaTech International, Inc. — Grove City

Identifiers

NCT: NCT02844738 · IRCM-2016-113

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗