A Study Assessing the Safety of Cord Blood Product in Sacroiliac Joint Syndrome (SIJ) (NCT06415461) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study Assessing the Safety of Cord Blood Product in Sacroiliac Joint Syndrome (SIJ)
United States9 participantsStarted 2024-05-10
Plain-language summary
This is a Phase 1 trial. The overall objective is to evaluate the safety and potential efficacy effect of specific type of umbilical cord blood product (CFL001), which, other than specific modifications in manufacturing to render it compatible with current Good Manufacturing Practice (cGMP), is essentially similar to that reported in real-world experience.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years and ≤ 90 years.
✓. Diagnosis of SIJ syndrome based on clinical findings, including the Fortin, FABER and compression sign.
✓. Severity of Sacroiliac Joint (SIJ) syndrome with a baseline Oswestry Disability Index (ODI) score ≥ 30% and an SI joint pain score of ≥ 50 and ≤ 90 on the Visual Analogue Scale (VAS) 100 mm scale.
✓. Individuals with either unilateral or bilateral SIJ arthritis can be candidates for enrollment; if both joints are deemed appropriate for administration of the test agent by all other inclusion criteria, then the SIJ which the participants reports as more painful will be treated, or if both are equally painful then we will use a random generator approach ("flip a coin") to determine which joint will be treated.
✓. ≥75% decrease in pain within 2 days after image-guided injection of only local anesthetic (with no steroid) into the SIJ within 3 months prior to screening.
✓. Body mass index \< 40 kg/m2.
✓. Ability to comply with the requirements of the study.
✓. Ability to understand and provide written informed consent.
Exclusion criteria
✕. Prior radiation to the SIJ.
✕. Use of any pain medication or therapy less than 15 days prior to test product administration that has not or will not have had a stable dosage, frequency, or intensity for at least 3 months prior to test agent administration. Use of scheduled pain medication other than acetaminophen for conditions unrelated to SIJ syndrome that has not had a stable dosage for at least 3 months prior to test agent administration. Unwillingness to consider avoiding the use of pain medication for at least 24 hours prior to each follow up evaluation.
What they're measuring
1
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
Timeframe: 7, 30, 90, and 180 days post dose
2
Number of participants with treatment-related adverse events as assessed by CTCAE v.5 and assessment of protocol defined study endpoints
✕. Intra-articular treatment with corticosteroids or systemic steroid use within 3 months prior to screening.
✕. Intra-articular treatment with regenerative medicines (e.g., plasma, stem cell, placental products) at any point prior to screening.
✕. Participated in another clinical trial within the last 6 months.
✕. An absolute value vital sign outside the following ranges: Systolic blood pressure \>170 or \<100, pulse rate of \>100 or \<50 bpm, and respiratory rate \>22. Reasonable delay (i.e., one hour) may be provided at investigator's discretion to evaluate for return to acceptable parameters in the event that the subject had been subjected to a stressful circumstance prior to arrival in clinic.
✕. Intra-articular treatment with hyaluronic acid within 6 months prior to screening.
✕. Surgical intervention on the index SIJ \< 12 months, or arthroscopy \< 3 months prior to screening.