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Stem Cell Therapy

Cord Blood Product for Sacroiliac Pain (SIJ Trial)

Phase 1

Recruiting

Led By Rene Przkora, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years and ≤ 90 years

Established SIJ condition based on decrease in pain after image-guided injection of local anesthetic and steroid into the SIJ 3 months prior to screening

Must not have

Past or current diagnosis of fibromyalgia or inflammatory arthritis, gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, active infection of the SIJ or at the site of injection, pes anserine bursitis, neurogenic or vascular claudication, or uncontrolled diabetes mellitus (HbA1C >8%)

Poorly controlled condition anticipated to have a likelihood of steroid requirement during the course of the trial that could potentially confound the outcomes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7, 30, 90, 180 days post dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is in the early stages (Phase 1) and aims to test the safety and effectiveness of a particular type of umbilical cord blood product called CFL001. The product has been modified

Who is the study for?

This trial is for individuals experiencing back pain, specifically sacroiliac joint syndrome. Details on who can join or reasons for exclusion are not provided.

What is being tested?

The study is testing the safety and potential effectiveness of a cord blood product called PremierMaxCB®-Platinum (CFL001) in treating sacroiliac joint syndrome. It's an open-label, early-phase trial without specific details on study design.

What are the potential side effects?

Since this is a Phase 1 safety trial, side effects are being assessed but not specified here. Participants will be monitored for any adverse reactions to CFL001.

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 SIJ pain decreased after a targeted injection 3 months ago.

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I've tried medications, daily exercises, and physical therapy for 3 months without relief from pain.

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My back pain is severe, with high scores on specific pain and disability scales.

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My pain decreased by 75% or more within 2 days after a special pain relief injection in my joint.

Exclusion Criteria

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

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I do not have fibromyalgia, severe arthritis, uncontrolled diabetes, or other listed conditions.

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I might need steroids during the trial, which could affect the results.

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I have had radiation therapy to my sacroiliac joint.

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I have or had cancer, or it's likely to come back.

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I need fluid drained from my sacroiliac joint for diagnosis or to relieve symptoms.

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I am not pregnant or breastfeeding.

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I have not had a joint treatment with hyaluronic acid in the last 6 months.

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I have had a major injury to my pelvis in the last year.

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I have a bone condition affecting my metabolism.

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I am receiving disability or worker's compensation for back or SI joint pain.

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I have had joint treatments with regenerative medicines like plasma or stem cells.

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I cannot walk by myself.

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I am allergic to local anesthetics or DMSO.

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I do not have severe heart issues, active hepatitis, serious liver problems, blood clotting disorders, very low kidney function, or recent untreated cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7, 30, 90, 180 days post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7, 30, 90, 180 days post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7, 30, 90, 180 days post dose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with treatment-related adverse events as assessed by CTCAE v.5 and assessment of protocol defined study endpoints

Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v.5 and assessment of protocol defined study endpoints

Secondary study objectives

CFL001 Efficacy