Cord Blood Product for Sacroiliac Pain
(SIJ Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Florida
Must not be taking: Steroids, Regenerative medicines
Disqualifiers: Fibromyalgia, Inflammatory arthritis, Diabetes, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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 Manufacuring Practice (cGMP), is essentially similar to that reported in real-world experience.
Will I have to stop taking my current medications?
The trial requires that any pain medication or therapy you are using must have a stable dosage for at least 3 months before starting the trial. You also need to avoid using pain medication for at least 24 hours before each follow-up evaluation.
What data supports the effectiveness of the treatment PremierMaxCB®-Platinum (CFL001) for sacroiliac pain?
Research shows that expanding cord blood cells can improve their effectiveness in treatments, as seen in studies where cord blood cells were expanded using various techniques, leading to increased cell numbers and improved outcomes in other conditions. This suggests potential benefits for treatments like PremierMaxCB®-Platinum.
12345How is the treatment PremierMaxCB®-Platinum (CFL001) unique for sacroiliac pain?
PremierMaxCB®-Platinum (CFL001) is unique because it uses cord blood, which contains hematopoietic stem cells, potentially offering regenerative properties that are not typical in standard treatments for sacroiliac pain. This approach may provide a novel mechanism of action by promoting tissue repair and regeneration.
23678Eligibility Criteria
This trial is for individuals experiencing back pain, specifically sacroiliac joint syndrome. Details on who can join or reasons for exclusion are not provided.Inclusion Criteria
I am using effective birth control during the study.
I've tried medications, daily exercises, and physical therapy for 3 months without relief from pain.
Body mass index < 40 kg/m2
+8 more
Exclusion Criteria
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
Active alcohol or substance abuse or any other reason that makes it unlikely that the subject will comply with study procedures
+27 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive varying doses of CFL001 cord blood product to assess safety and tolerability
Approximately 4 weeks
3 visits (in-person) for dose administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
26 weeks
4 visits (in-person) at 7, 30, 90, and 180 days post dose
Participant Groups
The study is testing the safety and potential effectiveness of a cord blood product called PremierMaxCB®-Platinum (CFL001) in treating sacroiliac joint syndrome. It's an open-label, early-phase trial without specific details on study design.
3Treatment groups
Experimental Treatment
Group I: Arm 3: High DoseExperimental Treatment1 Intervention
The next three subjects will receive the 90 x 106 TNC dose.
Group II: Arm 2: Medium DoseExperimental Treatment1 Intervention
The next three subjects will receive the 60 x 106 TNC dose.
Group III: Arm 1: Low doseExperimental Treatment1 Intervention
The first three subjects will receive the 30 x 106 TNC dose.
PremierMaxCB®-Platinum (CFL001) is already approved in United States for the following indications:
🇺🇸 Approved in United States as HPC Cord Blood for:
- Blood cancers
- Genetic disorders
- Immunological disorders
- Anemia
- Leukemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Florida Pain ClinicGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
Cord for Life, Inc.Collaborator
References
Superior ex vivo cord blood expansion following co-culture with bone marrow-derived mesenchymal stem cells. [2022]One factor limiting the therapeutic efficacy of cord blood (CB) hematopoietic progenitor cell (HPC) transplantation is the low cell dose of the graft. This is associated with an increased incidence of delayed or failed engraftment. Cell dose can be increased and the efficacy of CB transplantation potentially improved, by ex vivo CB expansion before transplantation. Two ex vivo CB expansion techniques were compared: (1) CD133+ selection followed by ex vivo liquid culture and (2) co-culture of unmanipulated CB with bone-marrow-derived mesenchymal stem cells (MSCs). Ex vivo culture was performed in medium supplemented with granulocyte colony-stimulating factor, stem cell factor and either thrombopoietin or megakaryocyte growth and differentiation factor. Expansion was followed by measuring total nucleated cell (TNC), CD133+ and CD34+ cell, colony-forming unit and cobblestone area-forming cell output. When compared to liquid culture, CB-MSC co-culture (i) required less cell manipulation resulting in less initial HPC loss and (ii) markedly improved TNC and HPC output. CB-MSC co-culture therefore holds promise for improving engraftment kinetics in CB transplant recipients.
The Milan Cord Blood Bank and the Italian Cord Blood Network. [2006]We describe the activities of the Milan Cord Blood (CB) Bank and of the Italian Cord Blood Network. By October 31, 1995, 763 units were banked in Milan. Of these, 8 units were used to perform 4 related and 4 unrelated transplants in 5 children and 3 adult patients. Early cord clamping after delivery was found to be crucial to increase the volume of CB collected. This procedure does not seem to be detrimental to the newborn. Of various red cell sedimenting agents used to reduce the unit volume and concentrate progenitor cells, 3% gelatin seems to be associated with the best yields. After a preliminary experience of 2 years, the Italian Cord Blood Network (Gruppo Italiano Amplificazione Cellule Emopoietiche, GRACE) was founded in 1995. The initial activities of GRACE are aimed at the development at the national level of CB banking standard operative procedures in agreement with the draft issued by The North American Task Force for The Development of Standards for Hematopoietic Cell Transplantation. Moreover, a wet workshop has been organized to standardize colony-forming unit (CFU) evaluation. The main goal in Milan is the collection of 5000 CB units. Other issues of interest include CB volume reduction, hematopoietic progenitor purification, ex vivo expansion prior to transplantation, and experimental protocols for gene transfer, such as those related to the multidrug resistance (MDR) gene.
Long-term expansion and maintenance of cord blood haematopoietic stem cells using thrombopoietin, Flt3-ligand, interleukin (IL)-6 and IL-11 in a serum-free and stroma-free culture system. [2019]Although cord blood (CB) compares favourably with other haematopoietic stem cell (HSCs) sources, its use in large patients is limited by the low number of cells available. Ex vivo expansion of CB HSCs has been used to overcome this limitation. In this study, we investigated the effect of different cytokine cocktails, including interleukin (IL)-6, IL-11, Flt3-ligand (FL) and thrombopoietin (TPO) combined with serum or serum-free medium on the ex vivo expansion of CD34+ cells from CB. Initial experiments showed that expansion could be slightly improved using serum, but we chose to use serum-free medium in the subsequent investigations to apply good medical practice (GMP) conditions suitable for clinical use. The highest expansion of CD34+ cells was obtained with a cocktail containing FL + TPO + IL-6 + IL-11. The median (range) fold expansions of CD34+ cells at 5 and 10 weeks with serum-free medium were 235.6 (131.3-340) and 5205.6 (4736.6-5674.7) respectively. The absence of IL-11 was associated with a similar fold expansion after 5 weeks (median 215.6, range 149.8-281.5), but after 10 weeks expansion was slightly lower (median 1314.7, range 645-1984.4). Our data support the possibility of maintaining long-term expansion of CB HSCs in a simple stroma- and serum-free system.
Human umbilical cord blood-derived stromal cell, a new resource of feeder layer to expand human umbilical cord blood CD34+ cells in vitro. [2006]Allogeneic transplantation with human umbilical cord blood (hUCB) in adult recipients is mainly limited by a low CD34+ cell dose. To break the limit, hUCB as a novel source of hUCB-derived stromal cells was incorporated in an attempt to expand CD34+ cells from hUCB in vitro. Cord blood CD34 cells were separated by MACS system. HUCB-derived stromal cells were cultured by the Dexter system and characterized by morphologic, immunophenotypical, and functional analysis. We studied the effects of hUCB-derived stromal cells, cytokines, and hUCB-derived stromal cells combined with cytokines on expansion of hUCB CD34 cells. The CD34+ cells were assessed for the degree of expansion and the number of colony-forming units in semisolid culture. Our research found that hUCB-derived stromal cells were mainly composed of three kinds of cell components, with CD106, CD29, CD44, CD45, CD50, CD68, CD31, Fn, Lm, and collagen IV positive, but CD34 negative immunophenotype. Functionally, it was discovered by cell cycle and growth curve analyses that the capability of colony and parietal layer formation of hUCB-derived stromal cells was poorer than that of BM stromal cells, and the doubling time of hUCB-derived stromal cells was longer than that of BM stromal cells. It was indicated by ELISA and RT-PCR that hUCB-derived stromal cells express higher level of TPO and less GM-CSF and SCF than BM stromal cell. Adherent layer of hUCB-derived stromal cells alone or combining with cytokines, increased CD34+ cell expansion. In vitro formation of CFUs by expanded CCD34 cells was significantly higher than that of unexpanded CD34+ cells (P
Effective expansion of umbilical cord blood hematopoietic stem/progenitor cells by regulation of microencapsulated osteoblasts under hypoxic condition. [2009]The expansion of hematopoietic stem/progenitor cells (HSPCs) from umbilical cord blood (UCB) with the support of microencapsulated osteoblasts under hypoxia environment was investigated. The expansion of HSPCs was evaluated through the total number of UCB mononuclear cells (MNCs) produced, their repopulating potential with the colony-forming unit assay (CFU-Cs) and CD34(+) phenotypic analysis with flow cytometry. At the end of 7 days of culture, the UCB-MNCs, CFU-Cs and CD34(+) cells had achieved 18.7 +/- 1.6, 11.6 +/- 0.9 and 23.4 +/- 2-fold expansions, respectively, in the test groups. These were significantly different from those in control groups. Microencapsulated osteoblasts under hypoxia conditions had therefore a significant effect on the expansion potential of HSPCs in vitro.
Impressive tissue regeneration of severe oral mucositis post stem cell transplantation using cord blood platelet gel. [2018]Platelet gel from cord blood (CBPG) is a recently developed blood component for topical use. We report a case of life-threatening mucositis after high-dose chemotherapy with fotemustine and cytarabine that was successfully treated with CBPG.
[Cord blood plasma selectively stimulates the expansion of hematopoietic pregenitor cells in vitro]. [2004]To explore the effect of cord blood (CB) plasma on the expansion of hematopoietic progenitor cells.
Evaluation of nonleukoreduced red blood cell transfusion units collected at delivery from the placenta. [2007]The objective of this study was to evaluate the suitability of cord blood (CB) as a source of red blood cells (RBCs) for autologous transfusion.