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Regenerative Medicine

Cell Therapy for Knee 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 with indication of Osteoarthritis, grade 2 or more from degeneration or chronic injury
Must not have
Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
Patients infected with hepatitis B, C or HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 and (6 - 12 months optional)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a therapy using the patient's own cells helps knee osteoarthritis pain & inflammation. 50 patients tested, then 4,000 more.

Who is the study for?
This trial is for adults aged 18-90 with knee pain from osteoarthritis (grade 2 or higher) for over 6 months. Participants should have good immune, kidney, blood coagulation, heart and lung function. Excluded are those with recent steroid injections or strokes, heavy NSAID use before the procedure, certain cancers within 5 years, severe obesity (BMI >40), infections including hepatitis B/C or HIV, gout conditions and strong opioid use recently.
What is being tested?
The study tests the safety and effectiveness of autologous cell therapy using StroMed combined with platelet rich plasma (PRP) versus PRP alone in reducing knee pain and inflammation due to osteoarthritis. It's an open-label trial starting with 50 patients followed by a larger group of up to 4,000 participants.
What are the potential side effects?
While specific side effects aren't listed here, similar therapies may cause injection site reactions like pain or swelling; risk of infection; allergic reactions; temporary increase in inflammation; bleeding due to blood thinning effect of PRP.

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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I have moderate to severe osteoarthritis.
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I have had knee pain for more than 6 months.
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My immune system is healthy and I don't have an immunodeficiency disease.

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 am infected with hepatitis B, C, or HIV.
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I have a serious heart or stroke condition.
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I currently have an active infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 and (6 - 12 months optional)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 and (6 - 12 months optional) 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 KOOS survey (Knee Osteoarthritis Outcome Score)
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment2 Interventions
Interventions assigned by Principal Investigator
Group II: Cohort 1Experimental Treatment2 Interventions
Interventions assigned by Principal Investigator

Find a Location

Who is running the clinical trial?

VivaTech International, Inc.Lead Sponsor
2 Previous Clinical Trials
8,000 Total Patients Enrolled
2 Trials studying Osteoarthritis
8,000 Patients Enrolled for Osteoarthritis
Mark LoDico, MDPrincipal InvestigatorAdvanced Regenerative Medicine
2 Previous Clinical Trials
8,000 Total Patients Enrolled
2 Trials studying Osteoarthritis
8,000 Patients Enrolled for Osteoarthritis

Media Library

Platelet Rich Plasma (PRP) (Regenerative Medicine) Clinical Trial Eligibility Overview. Trial Name: NCT02844751 — Phase 2
Osteoarthritis Research Study Groups: Cohort 2, Cohort 1
Osteoarthritis Clinical Trial 2023: Platelet Rich Plasma (PRP) Highlights & Side Effects. Trial Name: NCT02844751 — Phase 2
Platelet Rich Plasma (PRP) (Regenerative Medicine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02844751 — Phase 2
~231 spots leftby Aug 2025
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