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Platelet Rich Plasma

Cell Therapy for Shoulder Osteoarthritis

Phase 2

Recruiting

Led By Mark LoDico, MD

Research Sponsored by VivaTech International, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients range from 18-90 years of age

Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl

Must not have

Corticosteroid injection at treatment site within 1 month

Patients infected with hepatitis B, C or HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0,2,6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the safety and effectiveness of a shoulder pain and inflammation treatment using the patient's own cells. 50 patients will be studied, followed by a larger group of 4,000.

Who is the study for?

This trial is for adults aged 18-90 with shoulder pain from osteoarthritis lasting over 6 months. They must have good kidney, blood clotting, immune system function, and no immunodeficiency diseases. Excluded are those using strong painkillers or NSAIDs recently, with recent infections or cancer (except certain skin cancers), stroke history within six months, hepatitis B/C or HIV infection, very high BMI (>40kg/m2), unstable heart conditions, or steroid injections in the last month.

What is being tested?

The study tests a combination of StroMed and platelet rich plasma (PRP) to treat shoulder pain and inflammation due to osteoarthritis. It's an open-label trial starting with 50 patients to assess safety and effectiveness before expanding to a larger group of 4,000 participants.

What are the potential side effects?

While specific side effects aren't listed here, similar treatments may cause injection site reactions like pain or swelling, potential risk of infection at the injection site; allergic reactions; temporary increase in inflammation; and possible systemic responses if cells travel beyond the target area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 90 years old.

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My kidney function is good, with creatinine levels at or below 1.5 mg/dl.

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My immune system is healthy and I don't have an immunodeficiency disease.

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I have had shoulder pain for more than 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a steroid injection at the treatment site in the last month.

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I am infected with hepatitis B, C, or HIV.

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I currently have an active infection.

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I do not have any recent serious heart or stroke issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0,2,6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0,2,6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0,2,6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change is being assessed by MRI of afflicted joint

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

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: StroMed + platelet rich plasma (PRP)Experimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met