Alocyte for Back Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Alimorad Farshchian
Must not be taking: Anticoagulants, NSAIDs, Narcotics, Corticosteroids
Disqualifiers: Surgical intervention, Severe stenosis, Rheumatologic disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing Alocyte, a treatment made from umbilical cord blood, on patients with back pain due to issues in their spine joints. Current treatments don't fix the underlying problem. Alocyte aims to reduce inflammation and help the body repair itself, potentially providing longer-lasting relief. Amniotic membrane and umbilical cord (AMUC) particulate may be useful in relieving pain and inhibiting the degenerative cascade in patients with discogenic pain by reducing inflammation.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications, such as anticoagulants, NSAIDs, chronic narcotics, and corticosteroids, before and during the study. If you're on any of these, you may need to stop them for a specific period before participating.
What evidence supports the effectiveness of the treatment Alocyte, which includes cord blood plasma and mononuclear cells, for back pain?
Research shows that umbilical cord blood, which contains mononuclear cells, has been used effectively in treating various diseases and injuries, including neurological conditions and tissue repair. This suggests potential benefits for regenerative therapies, which might help with conditions like back pain.
12345Is Alocyte safe for use in humans?
Research on using umbilical cord blood cells, like those in Alocyte, shows they are generally safe for treating various conditions. Some studies report minor side effects, such as tingling sensations, which can be easily managed with calcium supplements.
36789How is the treatment Alocyte for back pain different from other treatments?
Alocyte is unique because it involves the use of cord blood plasma and mononuclear cells, which are components that may stimulate the expansion of specific cell types, potentially offering a novel approach to treating back pain compared to traditional methods.
1011121314Eligibility Criteria
This trial is for men and women over 18 with chronic back pain from facet joint issues, who've tried other treatments without success. They must be able to attend follow-ups and use contraception if of childbearing potential. Exclusions include severe diseases like cancer, liver or kidney disease, heart failure, bleeding disorders, recent other trials or treatments for back pain.Inclusion Criteria
My back pain is diagnosed as facetogenic.
I have up to 5 affected facet joints.
I have had back pain for over 6 months and treatments haven't worked.
+6 more
Exclusion Criteria
I do not have any uncontrolled health conditions like high blood pressure or severe asthma.
My MRI shows severe narrowing in my lower back.
I have severe chronic kidney disease or need dialysis.
+26 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Alocyte injections in facet joints at low, medium, or high doses
1 month
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Multiple visits (in-person) at 1, 3, 6, and 12 months
Extension
Participants may continue to be monitored for long-term safety and efficacy
Long-term
Participant Groups
The study tests Alocyte at three different doses to see if it's safe and can reduce inflammation or relieve chronic back pain caused by facet joint degeneration. It involves injecting a combination of cord blood plasma and cells into the affected area.
3Treatment groups
Experimental Treatment
Group I: Alocyte Medium doseExperimental Treatment1 Intervention
Subjects will receive medium dose injections in three facet joints
Group II: Alocyte Low doseExperimental Treatment1 Intervention
Subjects will receive low dose injection in a single facet joint
Group III: Alocyte High doseExperimental Treatment1 Intervention
Subjects will receive high dose injections in five facet joints
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Center for Regenerative MedicineNorth Miami, FL
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Who Is Running the Clinical Trial?
Alimorad FarshchianLead Sponsor
References
Cord blood transplantation and stem cell regenerative potential. [2011]The past 20 years of experience with umbilical cord blood transplantation have demonstrated that cord blood is effective in the treatment of a spectrum of diseases, including hematological malignancies, bone marrow failure, hemoglobinopathies, and inborn errors of metabolism. Cord blood can be obtained with ease and then safely cryopreserved for either public or private use without loss of viability. As compared to other unrelated donor cell sources, cord blood transplantation allows for greater human leukocyte antigen disparity without a corresponding increase in graft-vs.-host disease. Moreover, cord blood has a lower risk of transmitting infections by latent viruses and is less likely to carry somatic mutations than other adult cells. Recently, multiple populations of stem cells with primitive stem cell properties have been identified from cord blood. Meanwhile, there is an increasing interest in applying cord blood mononuclear cells or enriched stem cell populations to regenerative therapies. Accumulating evidence has suggested functional improvements after cord blood transplantation in various animal models for treatments of cardiac infarction, diabetes, neurological diseases, etc. In this review, we will summarize the most recent updates on clinical applications of cord blood transplantation and the promises and limitations of cell-based therapies for tissue repair and regeneration.
Macrophage colony stimulating factor (M-CSF) within cord blood sera may be partially responsible for the reduced proliferation of cord blood T cells. [2006]We show that there are differences in the soluble factors in cord blood (CB) and adult serum and that these differences play a role in T cell function. Thus, the mitogen and alloantigen-specific proliferative response of adult T cells was enhanced with increasing concentrations of adult serum and CB serum, but to a lesser extent with CB serum. In addition, proliferation of T cells induced by stimulation through the T cell receptor alone (via CD3 stimulation), could be enhanced with adult but not CB serum. However, CB serum enhanced the IL-2-specific proliferative response of pure T cells whereas adult serum did not. To determine whether there was an anti-inflammatory cytokine within CB serum which could induce these results, we assayed our serum samples for anti-inflammatory cytokines. IL-13 could not be detected in any serum sample, whereas IL-10 could be detected in adult but not CB serum (P
Clinical safety in using unmatched allogeneic umbilical cord blood mononuclear cells transplantations in non-haematopoietic degenerative conditions. [2015]Evaluation of safety in using unmatched human allogeneic umbilical cord blood cells for therapeutic use in individuals with non-haematopoietic degenerative conditions.
Umbilical cord blood cells. [2015]The umbilical cord of a healthy neonate contains within it a multipotential treatment for a myriad of diseases and injuries. What was once tossed into the biohazard waste without a second thought is now known to be a goldmine of antigenically immature cells that rival the use of bone marrow for reconstitution of blood lineages. Umbilical cord blood (UCB) is emerging as an effective and feasible clinical treatment as its availability increases and benefits are realized. Basic science research has demonstrated a broad therapeutic capacity ranging from cell replacement to cell protection and anti-inflammation in a number of animal disease and injury models. UCB is easily obtained with no harm to infant or mother and can be stored at cryogenic temperatures with relatively little loss of cells upon thaw. The heterogeneous mononuclear fraction has been identified and characterized and transplanted both locally and systemically to treat animal models of stroke, myocardial infarction, Amytrophic Lateral Sclerosis, San Filippo, spinal cord injury, traumatic brain injury, and age-related neurodegeneration, among others. In the pages to follow, we share protocols for the identification and research use of the mononuclear cell fraction of UCB.
Characterization of natural killer and natural killer-like T cells derived from ex vivo expanded and activated cord blood mononuclear cells: implications for adoptive cellular immunotherapy. [2021]Cord blood (CB) is limited by the absence of available donor effector cells for post-unrelated CB transplantation adoptive cellular immunotherapy. We reported the ability to ex vivo expand (EvE) CB mononuclear cells (MNC) after short-term incubation with anti-CD3, interleukin (IL)-2, IL-7, and IL-12 (antibody/cytokine [AB/CY]) into subpopulations of CD3(-)/56(+) natural killer (NK) cells with enhanced in vitro and in vivo tumor cytotoxicity.
Adverse events in peripheral progenitor cell collection: a 7-year experience. [2004]Collection of peripheral progenitor cells (PPC) by apheresis machines is generally regarded as a safe procedure. However, data about adverse events in PPC harvesting are scarce. In a monocentric retrospective study, the data of 540 PPC collections in a period of 7 years were reviewed. Adverse events were subdivided in collection-associated technical problems and patient/donor-related side effects. Patient/donor-related side effects occurred most often (19.8%); most of them were paresthesias due to citrate toxicity. Paresthesias were treated by oral (20.4%) or intravenous (1.1%) calcium supplementation. Problems with venous access were also seen frequently, resulting in blood flow alarms (11.3%) and blockades in the return line (4.3%). A total of 6.9% of these problems were catheter associated, requiring revision of the central venous line in 2.6%. Technical problems with the blood cell separators were observed in 11.7%. Ten PPC collections were discontinued due to adverse events. The data of this retrospective, monocentric analysis show that patient/donor-associated problems were observed in every fifth PPC harvest. Most of them were paresthesias, which could be easily treated by calcium supplementation. Problems with venous access and technical problems with the cell separators occurred in every tenth PPC collection.
Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy. [2022]To assess feasibility and safety of providing autologous umbilical cord blood (UCB) cells to neonates with hypoxic-ischemic encephalopathy (HIE).
The Mannheim Cord Blood Bank: Experiences and Perspectives for the Future. [2021]SUMMARY: BACKGROUND AND METHODS: As a source of hematopoietic stem cells, cord blood (CB) is an alternative to bone marrow or peripheral blood stem cells (PBSC). The Mannheim Cord Blood Bank has currently stored about 1,750 allogeneic CB units. Here we report our experiences and discuss future perspectives of CB banking. We analyzed CB units for nucleated cell (NC), mononucleated cell (MNC) and CD34+ cell count, volume, colony-forming units (CFU-GM) as well as ethnic background of the donor. Transplanted CB units were analyzed for patient and transplant characteristics and compared to stored CB units. RESULTS: Only 25% of all collected CB units met storage criteria. Main reasons for exclusion were: i) insufficient volume (57.7%), ii) delayed arrival at the processing site (19.2%) and iii) little cell count (7.2%). Up to now 36 CB units have been released for transplantation mainly to children (62%). Transplant indications were hematological diseases, immune deficiencies and metabolic diseases. Transplanted CB units showed significantly higher cell counts compared to stored units (NC: 12.5 vs. 7.2 x 10(8), MNC: 4.7 vs. 2.9 x 10(8), CD34+ cells: 3.3 vs. 1.8 x 10(6), mean; p
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.
[Method for concentrating marrow stem cells using the IBM 2991 washer. Necessary preparation before in vitro treatment of bone marrow by pharmacologic or immunologic means]. [2019]The technique using the IBM 2991 blood cell processor is an effective technique for the concentration of mononuclear cells from large volumes of bone marrow. The marrow cells are layered on to Ficoll Metrizoate using the IBM processing set. The mononuclear cells and CFU-GM recoveries are in close relationship with the hematocrit of the cell suspension processed. Twenty two bone marrows have been collected and purified according to this protocol. The mononuclear cell recovery is an average of 78,3% (range: 44-92%) and the CFU-GM recovery is in average of 67,5% (range: 40-89%). At the end of the procedure the cell viability is satisfying (97,1% +/- 1,7 are trypan blue negatives). When it is necessary to remove from the bone marrow collected either malignant cells prior autologous bone marrow graft or T lymphocytes in an attempt to prevent GVHD in allogeneic BMT, the purity of marrow cell suspension become a fundamental parameter.
[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.
Effect of two-round Ficoll-Hypaque density gradient centrifugation on lymphocyte subsets and natural killer activity of umbilical cord blood mononuclear cells. [2006]Umbilical cord blood (CB) mononuclear cells (MNCs) obtained from Ficoll-Hypaque density gradient centrifugation (FDGC) are frequently contaminated with erythrocytes and nucleated erythroid precursors. The authors investigated the effect of two-round (2-r) FDGC on lymphocyte subsets and natural killer activity of CB and adult peripheral blood (APB) MNCs, in comparison with those obtained from conventional one-round (1-r) separation. The percentage of CD45-expressing CB MNCs was greatly increased after the second density step (p
Counter-flow elutriation of clinical peripheral blood mononuclear cell concentrates for the production of dendritic and T cell therapies. [2021]Peripheral blood mononuclear cells (PBMC) concentrates collected by apheresis are frequently used as starting material for cellular therapies, but the cell of interest must often be isolated prior to initiating manufacturing.
Establishment of long-term monocyte suspension cultures from normal human peripheral blood. [2019]The long-term suspension growth of normal, immature myeloid cells from fresh human cord blood was recently reported and required cells separated on supplemented discontinuous Percoll gradients, growth in media containing hydrocortisone and vitamins D3, and gentle, continuous agitation (13). When normal adult bone marrow (six donors) or blood from Epstein-Barr virus (EBV)-seropositive donors (nine donors) was used as a source of fresh human leukocytes, only short-term proliferation of myeloid cells was achieved with the same techniques. However, when leukocytes prepared from EBV seronegative normal adult peripheral blood were used, pure populations of monocytes and macrophages that replicate slowly in liquid suspension culture for greater than 5 mo were repeatedly obtained from three independent donors. These cultures consists of several morphologically distinguishable monocytic cell types, including an approximately 20% adherent macrophage population. The monocytic nature of these cultures was confirmed by cytochemical, immunological, and functional criteria. These monocytes retain a normal chromosome pattern and can be induced to differentiate to phagocytic cells by treatment with tetradecanylphorbal acetate. Eventually, the cultures terminate as nonreplicating mature macrophages. These liquid suspension cultures should be a valuable resource for morphological, biochemical, and functional studies of developing monocyte-macrophages and their interaction with other cell types in normal and various pathological situations.