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Platelet Rich Plasma

Cell Therapy for Hip 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 with adequate renal function, Creatinine ≤ 1.5 mg/dl

Patients must have adequate immune system function, with no known immunodeficiency disease

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0,2,6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a new treatment using patient's own cells can safely relieve hip arthritis pain and inflammation. Follow-up will include 4,000 patients.

Who is the study for?

This trial is for adults aged 18-90 with hip pain from osteoarthritis lasting over 6 months, who have good heart, lung, kidney function and blood coagulation. They must not be dependent on alcohol or drugs, have had certain cancers in the last 5 years, recent steroid injections at the site, or use strong opioids or NSAIDs shortly before treatment.

What is being tested?

The study tests a cell therapy combining StroMed and PRP to treat hip osteoarthritis pain and inflammation. It's an open-label trial starting with 50 patients to assess safety and effectiveness before expanding to follow up with a larger group of 4,000 patients.

What are the potential side effects?

While specific side effects are not listed here, autologous cell therapies like this one may cause injection site reactions such as pain or swelling, risk of infection due to immune system involvement and potential adverse reactions related to individual patient conditions.

Eligibility Criteria

Inclusion Criteria

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

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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 am between 18 and 90 years old.

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I have had hip pain for more than 6 months on one side.

Exclusion Criteria

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

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I haven't had cancer in the last 5 years, except for skin cancer that was removed.

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I have serious heart or stroke issues.

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

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I have not taken strong opioids for pain other than hip pain in the last 4 weeks.

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

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I had a mini-stroke within the last 6 months.

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I currently have an active infection.

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 HOOS survey (Hip Osteoarthritis Outcome Scores)

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 Quality of Life Survey)

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 (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product by direct injection to affected joints.

0 / 11Eligibility criteria met