The use of stem cells for treating patients who have suffered traumatic spinal cord injuries is still experimental and has not been approved by the U.S. Food and Drug Administration (FDA), but one clinical trial to test the effectiveness of stem cell injections was given the green light.
The Mayo Clinic enrolled 10 patients in the phase 1 clinical trial to test the safety and effectiveness of stem cell injections in patients who had suffered from paralysis following a traumatic spinal cord injury. A case study of one of the patients, a super-responder to the treatment, was recently published in Mayo Clinic Proceedings.
The treatment involved injections of stem cells derived from a patient’s fat into the spine. The first patient in the trial to receive the treatment demonstrated improved motor and sensory functions with no significant adverse effects from the treatment.
The patient had injured his spinal cord in his neck in a surfing accident and suffered complete loss of function below the injury site. The patient underwent surgery to decompress and fuse his cervical vertebrae and after receiving occupational and physical therapy, regained some sensory function and was able to move his arms and legs again. 6 months after the operation, the patient plateaued and there were no further improvements to movement and sensory function.
The patient was enrolled in the trial and received an injection of stem cells 9 months after the injury. The stem cells were harvested from his abdominal fat and expanded to 100 million cells in the lab. The cells were introduced into his lumbar spine two months later.
The patient was monitored over the following 18 months, during which time considerable improvements were made to sensory and motor function. Prior to the stem cell injection, the patient took 57.72 seconds to complete a 10M walk test. After 15 months he was able to complete the walk in 23 seconds. His ambulation test scores also significantly improved, from 12.8 minutes to walk 635 feet to 2,200 feet in 34 minutes 15 months after treatment. The patient also saw improvements in his mental health score, manual dexterity improved, as did his occupational therapy and pinch and grip scores.
How stem cells injections help patients recover is not very well understood. It is known that the stem cells migrate to areas of highest inflammation, which is the site of the spinal injury, but how they interact with other cells when they get there is not known. The researchers have been investigating the mechanisms involved by searching for biological markers in the cerebrospinal fluid, but it is currently unclear how the stem cells interact at the site of injury.
The patient was a super-responder to the treatment, but other patients only saw a moderate level of improvement, and some did not respond to the treatment at all. The researchers are trying to determine why patients respond differently. That information would help them to select patients for stem cell injections who are most likely to respond.
Further case studies will be published by the Mayo Clinic on other patients, but the initial findings of the study will offer some hope to patients who have suffered traumatic spinal cord injuries and have lost sensory and motor function.
The case study is detailed in the paper – 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 – which was recently published in Mayo Clinic Proceedings. DOI: 10.1016/j.mayocp.2019.10.008