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Stem Cell Therapy

Stem Cell Therapy for Osteoarthritis

N/A

Recruiting

Led By Robert Vandermark, MD

Research Sponsored by InGeneron, Inc.

Eligibility Criteria Checklist

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

Must have

Males and females ages: 18 - 75

Clinical symptoms consistent with wrist osteoarthritis

Must not have

Subjects with a documented history or presence of inflammatory arthritis, rheumatoid arthritis, severe osteoporosis, sepsis, and chondrocalcinosis in the wrist

Subjects with a documented diagnosis of carpal tunnel syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat wrist osteoarthritis by injecting ADRCs generated by the Transpose RT system. The trial will compare the safety and efficacy of this new treatment to a standard treatment.

Who is the study for?

Adults aged 18-75 with chronic wrist osteoarthritis confirmed by symptoms and radiographs, who can consent to participate. Excluded are pregnant or breastfeeding individuals, recent tobacco users, those with substance abuse history, certain infections (HIV, Hepatitis B/C), allergies to specific anesthetics or contrast agents, participants in other trials, chemotherapy patients, vulnerable populations unable to consent properly (e.g., mentally disabled), and those with inflammatory arthritis conditions or carpal tunnel syndrome.

What is being tested?

The study is testing the safety and effectiveness of a single injection of adipose-derived stem cells (ADRCs) compared to corticosteroid injections for treating chronic wrist osteoarthritis. Participants will be randomly assigned to receive either ADRCs or corticosteroids without knowing which one they get.

What are the potential side effects?

Possible side effects may include reactions at the injection site such as pain or swelling, allergic reactions to the injected materials or local anesthetics used during the procedure. There's also a risk of infection following any injection.

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 75 years old.

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I have symptoms like pain or stiffness in my wrist.

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My wrist arthritis was confirmed by X-ray.

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I can make my own medical decisions or have someone who can.

Exclusion Criteria

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

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I have a history of severe joint or bone conditions, including arthritis or osteoporosis.

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I have been diagnosed with carpal tunnel syndrome.

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I don't have enough body fat to safely remove 100ml of it.

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I haven't had cancer in the limb or body in the last 5 years.

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I have received a corticosteroid injection at the site needing treatment.

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I am currently on chemotherapy.

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I have a history of HIV, Hepatitis B, or Hepatitis C.

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I am allergic to sodium citrate or 'caine' anesthetics.

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I am on chronic immunosuppressive therapy or have a severe autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 and 12 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

Safety - Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits

Efficacy - Change in Function Scores on the QuickDASH at All Follow-up

Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits

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

Active Control

Group I: Adipose Derived Regenerative Cell groupExperimental Treatment1 Intervention

Subjects in the treated group will receive an Adipose derived regenerative cells (ADRCs) injection into the wrist using a fluoroscopic-guided injection .

Group II: Corticosteroid groupActive Control1 Intervention

Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection.

0 / 13Eligibility criteria met