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Tests treatment safety and results for Facet Joints; Degeneration
Official title Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Back Pain
ClinicalTrials.gov ID: NCT05909709
What this study is testing
What is Alocyte low dose?
Alocyte low dose is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for facet joints; degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, all individuals must meet all of the following criteria:
- people 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 people who have chronic low back pain based on clinical evaluation. Pain...
You likely can't join if
- 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
See the full eligibility criteria
- In order to be eligible to participate in this study, all individuals must meet all of the following criteria:
- people 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 people who have chronic low back pain based on clinical evaluation. Pain onset at dorsal extension and release at flexion is often considered...
- Patient with up to 5 diseased facet joints
- Chronic Facetogenic pain (≥ 6 months) in patients that have failed conservative management
- people 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.
- 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...
- people 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...
- Have a clinical history of malignancy within 5 years (i.e., people with prior malignancy must be disease free for 5 years), except curatively treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or...
- 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.
- people 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 people must undergo a blood pregnancy test at screening which will be within 72 hours of...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- North Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.