Stem Cell Therapy for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen ByMohamad Bydon, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this research study is to investigate the safety and potential therapeutic effects of autologous, culture-expanded, adipose derived mesenchymal stem cell intrathecal injections in the treatment of spinal cord injury.
Do I have to stop taking my current medications for the trial?The trial requires that you stop taking certain medications. Specifically, you cannot be on chronic immunosuppressive therapy, systemic steroids, anti-rheumatic medications within 3 months prior to enrollment, or riluzole for ALS. If you are taking any of these, you will need to stop before participating.
What safety data exists for stem cell therapy in spinal cord injury?The CELLTOP Phase 1 clinical trial at Mayo Clinic reported that intrathecal administration of autologous adipose-derived mesenchymal stem cells (AD-MSCs) in a patient with spinal cord injury was feasible and safe, with no severe adverse events observed. The patient showed clinical signs of efficacy in motor and sensory scores over 18 months. This suggests that AD-MSCs may be a safe treatment option, warranting further clinical evaluation.23567
Is the treatment Autologous Adipose Derived Mesenchymal Stem Cells promising for spinal cord injury?Yes, the treatment using Autologous Adipose Derived Mesenchymal Stem Cells shows promise for spinal cord injury. Research indicates that these stem cells can help improve recovery and offer a new approach to treating spinal cord injuries.23456
What data supports the idea that Stem Cell Therapy for Spinal Cord Injury is an effective treatment?The available research shows that Stem Cell Therapy, specifically using adipose-derived stem cells, can improve recovery in spinal cord injury cases. Studies on rats have demonstrated that these stem cells help in functional recovery after spinal cord injury. For example, one study found that rats treated with these cells showed better movement abilities compared to those that did not receive the treatment. Another study compared different types of stem cells and found that adipose-derived cells were effective in improving neurological outcomes. These findings suggest that Stem Cell Therapy can be a promising treatment for spinal cord injuries.12456
Eligibility Criteria
Adults aged 18+ with traumatic, non-penetrating spinal cord injuries (SCI) graded A or B at injury time, who've seen no significant improvement for a year. Participants must understand and commit to the study's requirements including home exercises and follow-ups. Women of childbearing age need a negative pregnancy test and must use contraception during the study.Inclusion Criteria
My spinal cord injury was severe at first but improved within a year, though it has not gotten better since.
Exclusion Criteria
I have had treatments involving stem cells, gene therapy, or exosomes.
I can have an MRI and am willing to undergo MRI procedures.
I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.
I have had an infection in my spine before.
I currently have a skin infection near my spine.
I have a history of blood disorders such as anemia or low platelet counts.
I have a serious heart, brain, kidney, liver, or hormone-related condition.
I have a fever over 100.4 F or am experiencing confusion.
I have been diagnosed with schizophrenia or bipolar disorder.
I am currently taking riluzole for ALS.
I am on long-term medication that weakens my immune system.
My spinal cord injury is not classified as complete (A) or nearly complete (B).
My spinal cord injury was not caused by a physical injury.
Participant Groups
The trial is testing if one's own adipose-derived mesenchymal stem cells can safely improve SCI outcomes when injected into the spinal fluid, alongside standard occupational and physical therapy treatments.
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group 1: AD-MSC InjectionExperimental Treatment1 Intervention
Patients will receive a single dose of autologous, adipose derived mesenchymal stem cells one time. The cells are isolated from patient's adipose tissue and expanded for intrathecal delivery.
Group II: Treatment Group 2: Best Medical ManagementActive Control2 Interventions
Patients will be observed over six months while attending physical and occupational therapy. After six months, patients will receive a single dose of autologous, adipose derived mesenchymal stem cells one time. The cells are isolated from patient's adipose tissue and expanded for intrathecal delivery.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
Effects of differentiated versus undifferentiated adipose tissue-derived stromal cell grafts on functional recovery after spinal cord contusion. [2021]Controversies exist concerning the need for mesenchymal stromal cells (MSCs) to be transdifferentiated prior to their transplantation. In the present study, we compared the results of grafting into the rat contused spinal cord undifferentiated, adipose tissue-derived stromal cells (uADSCs) versus ADSCs induced by two different protocols to form differentiated nervous tissue. Using Basso, Beattie, and Bresnahan scores and grid tests, we found that three cell-treated groups, including uADSCs-treated, dADSCs induced by Protocol 1 (dADSC-P1)-treated, and dADSCs induced by Protocol 2 (dADSC-P2)-treated groups, significantly improved locomotor functional recovery in SCI rats, compared with the saline-treated group. Furthermore, functional recovery was better in the uADSC-treated and dADSC-P2-treated groups than in the dADSC-P1-treated group at week 12 postinjury (P
Comparison of mesenchymal stromal cells from human bone marrow and adipose tissue for the treatment of spinal cord injury. [2018]Bone marrow and subcutaneous adipose tissue are both considered prospective sources of mesenchymal stromal cells (MSCs), which can be used in cell therapy for spinal cord injury (SCI). The present study investigated whether human adipose tissue-derived mesenchymal stromal cells (hADSCs) transplanted into a rat model of SCI would lead to similar or improved neurologic effects compared with human bone marrow-derived mesenchymal stromal cells (hBMSCs).
Intrathecal transplantation of autologous adipose-derived mesenchymal stem cells for treating spinal cord injury: A human trial. [2018]Spinal cord injury (SCI) can cause irreversible damage to neural tissues. However, there is currently no effective treatment for SCI. The therapeutic potential of adipose-derived mesenchymal stem cells (ADMSCs) has been emerged.
The Effects of Adipose Tissue-Derived Mesenchymal Stem Cell Transplantation During the Acute and Subacute Phases Following Spinal Cord Injury. [2018]To investigate the effectiveness of rat adipose tissue-derived (rAT) mesenchymal stem cell (MSC) transplantation on the functional restoration and regeneration of spinal cord injury (SCI).
Infusion of autologous adipose tissue derived neuronal differentiated mesenchymal stem cells and hematopoietic stem cells in post-traumatic paraplegia offers a viable therapeutic approach. [2020]Spinal cord injury (SCI) is not likely to recover by current therapeutic modalities. Stem cell (SC) therapy (SCT) has promising results in regenerative medicine. We present our experience of co-infusion of autologous adipose tissue derived mesenchymal SC differentiated neuronal cells (N-Ad-MSC) and hematopoietic SCs (HSCs) in a set of patients with posttraumatic paraplegia.
Intravenous infusion of adipose-derived stem/stromal cells improves functional recovery of rats with spinal cord injury. [2018]Adipose tissue has therapeutic potential for spinal cord injury (SCI) because it contains multipotent cells known as adipose-derived stem/stromal cells (ASCs). In this study, we attempted intravenous ASC transplantation in rats with SCI to examine the effect on functional recovery.
CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury. [2020]Spinal cord injury (SCI) is a devastating condition with limited pharmacological treatment options to restore function. Regenerative approaches have recently attracted interest as an adjuvant to current standard of care. Adipose tissue-derived (AD) mesenchymal stem cells (MSCs) represent a readily accessible cell source with high proliferative capacity. The CELLTOP study, an ongoing multidisciplinary phase 1 clinical trial conducted at Mayo Clinic (ClinicalTrials.gov Identifier: NCT03308565), is investigating the safety and efficacy of intrathecal autologous AD-MSCs in patients with blunt, traumatic SCI. In this initial report, we describe the outcome of the first treated patient, a 53-year-old survivor of a surfing accident who sustained a high cervical American Spinal Injury Association Impairment Scale grade A SCI with subsequent neurologic improvement that plateaued within 6 months following injury. Although he improved to an American Spinal Injury Association grade C impairement classification, the individual continued to be wheelchair bound and severely debilitated. After study enrollment, an adipose tissue biopsy was performed and MSCs were isolated, expanded, and cryopreserved. Per protocol, the patient received an intrathecal injection of 100 million autologous AD-MSCs infused after a standard lumbar puncture at the L3-4 level 11 months after the injury. The patient tolerated the procedure well and did not experience any severe adverse events. Clinical signs of efficacy were observed at 3, 6, 12, and 18 months following the injection in both motor and sensory scores based on International Standards for Neurological Classification of Spinal Cord Injury. Thus, in this treated individual with SCI, intrathecal administration of AD-MSCs was feasible and safe and suggested meaningful signs of improved, rather than stabilized, neurologic status warranting further clinical evaluation.