A Study Assessing the Safety of Cord Blood Product in Sacroiliac Joint Syndrome (SIJ)

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 90 years.

2. Diagnosis of SIJ syndrome based on clinical findings, including the Fortin, FABERand compression sign.

3. Severity of Sacroiliac Joint (SIJ) syndrome with a baseline Oswestry DisabilityIndex (ODI) score ≥ 30% and an SI joint pain score of ≥ 50 and ≤ 90 on the VisualAnalogue Scale (VAS) 100 mm scale.

4. Individuals with either unilateral or bilateral SIJ arthritis can be candidates forenrollment; if both joints are deemed appropriate for administration of the testagent by all other inclusion criteria, then the SIJ which the participants reportsas more painful will be treated, or if both are equally painful then we will use arandom generator approach ("flip a coin") to determine which joint will be treated.

5. ≥75% decrease in pain within 2 days after image-guided injection of only localanesthetic (with no steroid) into the SIJ within 3 months prior to screening. OR Established SIJ condition based on decrease in pain after image-guided injectionof local anesthetic and steroid into the SIJ 3 months prior to screening.

6. Body mass index < 40 kg/m2.

7. Ability to comply with the requirements of the study.

8. Ability to understand and provide written informed consent.

9. All participants of reproductive age/capacity to confirm use of adequatecontraception during the study period.

10. All participants should have tried and failed conservative therapies such asmedications (acetaminophen and/or NSAIDs or Tramadol); daily home exercise or homestretching, including hip-girdle and core exercise, with the target of 20 minutes;and guided physical therapy at a facility once weekly for six weeks, if logisticallypractical. Failure of the above conservative therapeutic approaches is defined aspersistent pain after three months despite attempting the above.

Exclusion Criteria:

1. Prior radiation to the SIJ.

2. Use of any pain medication or therapy less than 15 days prior to test productadministration that has not or will not have had a stable dosage, frequency, orintensity for at least 3 months prior to test agent administration. Use of scheduledpain medication other than acetaminophen for conditions unrelated to SIJ syndromethat has not had a stable dosage for at least 3 months prior to test agentadministration. Unwillingness to consider avoiding the use of pain medication for atleast 24 hours prior to each follow up evaluation.

3. Intra-articular treatment with corticosteroids or systemic steroid use within 3months prior to screening.

4. Intra-articular treatment with regenerative medicines (e.g., plasma, stem cell,placental products) at any point prior to screening.

5. Participated in another clinical trial within the last 6 months.

6. 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. Reasonabledelay (i.e., one hour) may be provided at investigator's discretion to evaluate forreturn to acceptable parameters in the event that the subject had been subjected toa stressful circumstance prior to arrival in clinic.

7. Intra-articular treatment with hyaluronic acid within 6 months prior to screening.

8. Surgical intervention on the index SIJ < 12 months, or arthroscopy < 3 months priorto screening.

9. Non-ambulatory status.

10. 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, pesanserine bursitis, neurogenic or vascular claudication, or uncontrolled diabetesmellitus (HbA1C >8%).

11. Past or current diagnosis of concurrent diseases, including uncontrolledarrhythmias, Class 3 or 4 congestive heart failure, active hepatitis B or C, liverenzymes ≥ 2 times Upper Limit of Normal (ULN) if there is also elevation ofbilirubin, hypercoagulable state, estimated Glomerular Filtration Rate (eGFR) <45mL/min by chronic kidney disease Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), and untreated malignancy or malignancy diagnosed within 6 months.

12. Poorly controlled condition anticipated to have a likelihood of steroid requirementduring the course of the trial that could potentially confound the outcomes.

13. Past or current diagnosis of cancer, or at a high risk of recurrence.

14. Diagnosis of secondary arthritis due to traumatic injury in the index SIJ within 2years of screening.

15. SIJ effusion in the index SIJ at screening that requires drainage for diagnosticpurposes or symptomatic relief.

16. Clinically significant, ongoing illness or medical condition, that in the opinion ofthe investigator constitutes a safety risk for participation in the study or thatcould interfere with achieving the study objectives, conduct or evaluation.

17. Females who are pregnant or lactating.

18. Regular use of anticoagulants (daily use of aspirin < 325 mg is acceptable).

19. Active alcohol or substance abuse or any other reason that makes it unlikely thatthe subject will comply with study procedures.

20. Positive results on the urine drug screen for a banned substance or substance forwhich a subject does not have a valid prescription, using standard screen atclinical site.

21. Subjects with a psychiatric illness or condition, which, in the opinion of theinvestigation, would interfere with the conduct of the study or the interpretationof study results. Subjects with stable anxiety and depression defined as being onstable doses of antidepressant and anxiety drugs for the last 6 months and for whichno dose changes are expected during the study can be included.

22. Clinically significant medical, surgical, psychiatric, or laboratory abnormalitythat, in the judgment of the investigator, is likely to adversely affect thesubject's risk-benefit or interfere with study compliance or assessment of safety orefficacy.

23. Known allergy to local anesthetics or components of the study drug, includingdimethylsulfoxide (DMSO)

24. Known allergy to radiographic contrast.

25. Subjects with autoimmune disease or a known history of having AcquiredImmunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV).

26. Severe back pain due to other causes (e.g., lumbar disk degeneration, spinalstenosis), that in the opinion of the clinical investigator will render assessmentof the SIJ pain difficult or ambiguous.

27. History of recent (<1 year) major trauma to the pelvis.

28. Metabolic bone disease (either induced or idiopathic).

29. Involvement in litigation.

30. Receiving disability payments or worker's compensation for back or SI joint pain.