Is NCT05909709 recruiting in North Miami, FL?

Yes, NCT05909709 is currently recruiting participants at its North Miami, FL location. This facet joints; degeneration clinical trial is actively enrolling qualified participants.

How do I join the facet joints; degeneration clinical trial in North Miami?

To join this clinical trial in North Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this North Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Facet Joints; Degeneration Clinical Trial in North Miami, FL

About This Facet Joints; Degeneration Study in North Miami

The purpose of this study is to see if the use of Alocyte (cord blood plasma plus mononucleic cells) will be safe, well tolerated, and whether it causes any side effects. The study will also examine if the use of the Investigational Product (IP) is able to reduce local inflammation or alleviate Facetogenic back pain

Sponsor: Alimorad Farshchian

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, all individuals must meet all of the following criteria:

Subjects age \> 18 years at the time of signing the Informed Consent Form.

Male or Female.

Ability of participant to understand and the willingness to sign a written informed consent document.

Facetogenic back pain diagnosed using the following diagnostic criteria Subjects who have chronic low back pain based on clinical evaluation. Pain onset at dorsal extension and release at flexion is often considered suggestive for facet pain, even if non-specific, such as maximal tenderness upon deep palpation of posterior elements.

Patient with up to 5 diseased facet joints

Chronic Facetogenic pain (≥ 6 months) in patients that have failed conservative management

Subjects must be reasonably able to return for multiple follow-up visits.

For Women of Child-Bearing Potential (WOCBP) only, willingness to use FDA-recommended birth control until 6 months post treatment.

Any male subject must agree to use contraceptives and not donate sperm during the study.

Exclusion Criteria

Previous surgical intervention for back pain

Previous stem cell injection(s) within the last year

Use of anticoagulation or NSAIDs within 5 days of the injection

MRI finding of severe high-grade lumbar stenosis

Leg pain exceeding back pain

Pain worse with flexion maneuvers

Fracture of lumbar vertebrae

Inability to perform any of the assessments required for endpoint analysis.

Clinically significant abnormal screening laboratory or clinical assessment values

Use of medications during the early phase of treatment such as chronic narcotic use, systemic corticosteroid administration, local corticosteroid injection at facets anticoagulant therapy and viscosupplementation into facets, any investigational drug used within 3 months prior to screening or during study and surgery in the facets

Subjects with serious co-morbidities are excluded.

Evidence of inflammatory arthritis (example, rheumatoid arthritis and ankylosing spondylitis) or traumatic fractures, osteoarthritis, meniscoid entrapment, synovial impingement, joint subluxation, synovial inflammation, loss of cartilage, and mechanical injury.

Have a clinical history of malignancy within 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma, if recurrence occurs.

Be currently participating (or participated within the previous 6 months) in an investigational therapeutic or device trial.

Exhibiting signs of moderate or severe chronic respiratory disease (such as COPD, asthma, or pulmonary fibrosis).

Patient with rheumatologic disorders.

History of chronic liver disease or patient showing signs of clinical jaundice at the time of screening.

History of severe chronic kidney disease or requiring dialysis.

Patient with NYHA Class III or IV congestive heart failure or life-threatening arrhythmias.

Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to the treatment.

Any unstable condition of clinical significance, e.g., uncontrolled hypertension, unstable angina pectoris, worsening asthma.

Hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 21 days prior to the Day 0/treatment visit.

Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.

Subject has a body mass index (BMI) greater than 42 kg/m2

Subject has or had an active infection requiring systemic antibiotics within 12 weeks of enrollment in the study

Inability to perform any of the assessments required for endpoint analysis.

Active listing (or expected future listing) for transplant of any organ.

Be a solid organ transplant recipient. This does not include prior cell-based therapy (\>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection.

History of drug abuse (illegal "street" drugs except marijuana, if it is legal to use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months

Patients with untreated HIV infection. However, patients can be enrolled if have been treated for HIV and the test negative for HIV viral load but still test positive for antibodies.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in North Miami?

Yes, this clinical trial (NCT05909709) has an active research site in North Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Facet Joints; Degeneration Treatment Options in North Miami, FL

If you're searching for facet joints; degeneration treatment options in North Miami, FL, this clinical trial (NCT05909709) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our North Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced facet joints; degeneration specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all facet joints; degeneration clinical trials near you to find additional studies recruiting in your area.

Facet Joints; Degeneration Clinical Trial in North Miami, FL

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