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Sacroiliac; BackachePhase 1SIJNCT06415461

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

A Phase 1 study testing PremierMaxCB®-Platinum (CFL001); in people with Sacroiliac; Backache and Pain, Back, run by University of Florida at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Sacroiliac; Backache, Pain, Back
What is being tested?
PremierMaxCB®-Platinum (CFL001);
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
10 May 2024to 6 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • OR 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.
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  • Body mass index < 40 kg/m2.
  • Ability to comply with the requirements of the study.
  • Ability to understand and provide written informed consent.
  • All participants of reproductive age/capacity to confirm use of adequate contraception during the study period.
  • All participants should have tried and failed conservative therapies such as medications (acetaminophen and/or NSAIDs or Tramadol); daily home exercise or home stretching, 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 logistically practical. Failure of the above conservative therapeutic approaches is defined as persistent pain after three months despite attempting the above.

Who cannot join

  • 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.
  • 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.
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  • 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.
  • Non-ambulatory status.
  • 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%).
  • Past or current diagnosis of concurrent diseases, including uncontrolled arrhythmias, Class 3 or 4 congestive heart failure, active hepatitis B or C, liver enzymes ≥ 2 times Upper Limit of Normal (ULN) if there is also elevation of bilirubin, hypercoagulable state, estimated Glomerular Filtration Rate (eGFR) <45 mL/min by chronic kidney disease Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), and untreated malignancy or malignancy diagnosed within 6 months.
  • Poorly controlled condition anticipated to have a likelihood of steroid requirement during the course of the trial that could potentially confound the outcomes.
  • Past or current diagnosis of cancer, or at a high risk of recurrence.
  • Diagnosis of secondary arthritis due to traumatic injury in the index SIJ within 2 years of screening.
  • SIJ effusion in the index SIJ at screening that requires drainage for diagnostic purposes or symptomatic relief.
  • Clinically significant, ongoing illness or medical condition, that in the opinion of the investigator constitutes a safety risk for participation in the study or that could interfere with achieving the study objectives, conduct or evaluation.
  • Females who are pregnant or lactating.
  • Regular use of anticoagulants (daily use of aspirin < 325 mg is acceptable).
  • Active alcohol or substance abuse or any other reason that makes it unlikely that the subject will comply with study procedures.
  • Positive results on the urine drug screen for a banned substance or substance for which a subject does not have a valid prescription, using standard screen at clinical site.
  • Subjects with a psychiatric illness or condition, which, in the opinion of the investigation, would interfere with the conduct of the study or the interpretation of study results. Subjects with stable anxiety and depression defined as being on stable doses of antidepressant and anxiety drugs for the last 6 months and for which no dose changes are expected during the study can be included.
  • Clinically significant medical, surgical, psychiatric, or laboratory abnormality that, in the judgment of the investigator, is likely to adversely affect the subject's risk-benefit or interfere with study compliance or assessment of safety or efficacy.
  • Known allergy to local anesthetics or components of the study drug, including dimethylsulfoxide (DMSO)
  • Known allergy to radiographic contrast.
  • Subjects with autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV).
  • Severe back pain due to other causes (e.g., lumbar disk degeneration, spinal stenosis), that in the opinion of the clinical investigator will render assessment of the SIJ pain difficult or ambiguous.
  • History of recent (<1 year) major trauma to the pelvis.
  • Metabolic bone disease (either induced or idiopathic).
  • Involvement in litigation.
  • Receiving disability payments or worker's compensation for back or SI joint pain.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida Pain Clinic

    Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: A Phase 1, Open Label Dose-Ranging Study to Assess the Safety, Tolerability, Preliminary Efficacy, and Dose Effect of CFL001 Cord Blood Product in Patients With Symptomatic Sacroiliac Joint Syndrome

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.

Read the detailed description

The Phase 1 trial will enroll three subjects into an initial group receiving a low dose of CFL001. Provided that these subjects tolerate this dose well, will proceed to enroll three subjects into a group receiving a middle dose of CFL001. Provided that these subjects tolerate this dose well, will proceed to enroll three subjects into a group receiving the highest dose of CFL001.

All subjects will have Symptomatic Sacroiliac Joint (SIJ) syndrome, with clinical average pain score in the month prior to enrollment ≥50 and ≤90 on a 100-point scale.

Being tested
PremierMaxCB®-Platinum (CFL001);
Keywords
pain, sacroiliac joint syndrome
Medical subject headings
Back Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PremierMaxCB®-Platinum (CFL001);Biological

    Stem Cell: Human cell, tissue, and cellular or tissue-based product (HCT/P) manufactured from umbilical cord blood

Study groups in NCT06415461
Study groupRoleWhat they receive
Arm 1: Low doseExperimentalThe first three subjects will receive the 30 x 106 TNC dose.
Receives: Biological: PremierMaxCB®-Platinum (CFL001);
Arm 2: Medium DoseExperimentalThe next three subjects will receive the 60 x 106 TNC dose.
Receives: Biological: PremierMaxCB®-Platinum (CFL001);
Arm 3: High DoseExperimentalThe next three subjects will receive the 90 x 106 TNC dose.
Receives: Biological: PremierMaxCB®-Platinum (CFL001);

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    All Adverse events (types and frequencies) will be collected for all patients. Protocol defined study endpoints will also be collected on all patients. Study endpoints include:

    • Stopping criteria as defined in protocol

    Measured: 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

    Vital Sign Measurements (changes from baseline) Blood Pressure -systolic and diastolic (mm Hg)

    Measured: 7, 30, 90, and 180 days post dose

Secondary outcomes (3)

  1. CFL001 Efficacy

    Changes from baseline in overall activity obtained by actigraphy

    Measured: 7, 30, 90, and 180 days post dose

  2. CFL001 Efficacy

    Changes from baseline in patient reported outcomes with respect to SIJ and lower back pain measured the using the Visual Analog Scale (VAS)

    Measured: 7, 30, 90, and 180 days post dose

  3. CFL001 Efficacy

    Changes from baseline in Quality of Life Measured by Patient-Reported Outcomes Measurement Information System) PROMIS 29. Scales from 0-5 with a range of 4-10. Higher scores mean more of the concept being measured.

    Measured: 7, 30, 90, 180 days post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start10 May 2024
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion6 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose ranging study of increasing doses of cell product
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06415461
Sponsor's protocol ID
IRB202300181
Acronym
SIJ
Status last verified
Nov 2025
First submitted
26 May 2023
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pauza, K. (2008). Educational Guidelines for Interventional Spinal Procedures. https://www.aapmr.org/practice/guidelines/Documents/edguidelines.pdf. Accessed June 5 2015.

  • International Spine Intervention Society. (2004). Practice guidelines for spinal diagnostic and treatment procedures. San Rafael, CA: International Spine Intervention Society.

  • Jackson, R., & Porter, K. (2006). The pelvis and sacroiliac joint: Physical therapy patient management utilizing current evidence. In Current concepts of orthopaedic physical therapy. La Crosse, WI: American Physical Therapy Association.

  • Chevalier X, Goupille P, Beaulieu AD, Burch FX, Bensen WG, Conrozier T, Loeuille D, Kivitz AJ, Silver D, Appleton BE. Intraarticular injection of anakinra in osteoarthritis of the knee: a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2009 Mar 15;61(3):344-52. doi: 10.1002/art.24096.

    PubMed 19248129

  • Wu Y, Goh EL, Wang D, Ma S. Novel treatments for osteoarthritis: an update. Open Access Rheumatol. 2018 Oct 4;10:135-140. doi: 10.2147/OARRR.S176666. eCollection 2018.

    PubMed 30323693

  • van Drumpt RA, van der Weegen W, King W, Toler K, Macenski MM. Safety and Treatment Effectiveness of a Single Autologous Protein Solution Injection in Patients with Knee Osteoarthritis. Biores Open Access. 2016 Aug 1;5(1):261-8. doi: 10.1089/biores.2016.0014. eCollection 2016.

    PubMed 27668131

  • Vitale ND, Vandenbulcke F, Chisari E, Iacono F, Lovato L, Di Matteo B, Kon E. Innovative regenerative medicine in the management of knee OA: The role of Autologous Protein Solution. J Clin Orthop Trauma. 2019 Jan-Feb;10(1):49-52. doi: 10.1016/j.jcot.2018.08.019. Epub 2018 Aug 23.

    PubMed 30705532

  • Kon E, Engebretsen L, Verdonk P, Nehrer S, Filardo G. Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial. Am J Sports Med. 2018 Jan;46(1):171-180. doi: 10.1177/0363546517732734. Epub 2017 Oct 10.

    PubMed 29016185

  • Li X, Duan L, Liang Y, Zhu W, Xiong J, Wang D. Human Umbilical Cord Blood-Derived Mesenchymal Stem Cells Contribute to Chondrogenesis in Coculture with Chondrocytes. Biomed Res Int. 2016;2016:3827057. doi: 10.1155/2016/3827057. Epub 2016 Jun 30.

    PubMed 27446948

  • Ribatti D, Vacca A, Rusnati M, Presta M. The discovery of basic fibroblast growth factor/fibroblast growth factor-2 and its role in haematological malignancies. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):327-34. doi: 10.1016/j.cytogfr.2007.04.011. Epub 2007 May 29.

    PubMed 17537668

  • Lv YT, Zhang Y, Liu M, Qiuwaxi JN, Ashwood P, Cho SC, Huan Y, Ge RC, Chen XW, Wang ZJ, Kim BJ, Hu X. Transplantation of human cord blood mononuclear cells and umbilical cord-derived mesenchymal stem cells in autism. J Transl Med. 2013 Aug 27;11:196. doi: 10.1186/1479-5876-11-196.

    PubMed 23978163

  • Coutts M, Soriano R, Naidoo R, Torfi H. Umbilical cord blood stem cell treatment for a patient with psoriatic arthritis. World J Stem Cells. 2017 Dec 26;9(12):235-240. doi: 10.4252/wjsc.v9.i12.235.

    PubMed 29321825

  • Feng M, Lu A, Gao H, Qian C, Zhang J, Lin T, Zhao Y. Safety of Allogeneic Umbilical Cord Blood Stem Cells Therapy in Patients with Severe Cerebral Palsy: A Retrospective Study. Stem Cells Int. 2015;2015:325652. doi: 10.1155/2015/325652. Epub 2015 Jul 8.

    PubMed 26236347

  • Perrier S, Darakhshan F, Hajduch E. IL-1 receptor antagonist in metabolic diseases: Dr Jekyll or Mr Hyde? FEBS Lett. 2006 Nov 27;580(27):6289-94. doi: 10.1016/j.febslet.2006.10.061. Epub 2006 Nov 3.

    PubMed 17097645

  • Chevalier X, Giraudeau B, Conrozier T, Marliere J, Kiefer P, Goupille P. Safety study of intraarticular injection of interleukin 1 receptor antagonist in patients with painful knee osteoarthritis: a multicenter study. J Rheumatol. 2005 Jul;32(7):1317-23.

    PubMed 15996071

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PremierMaxCB®-Platinum (CFL001); in people with Sacroiliac; Backache and Pain, Back, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 7, 30, 90, and 180 days post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06415461, which also lists 71 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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