A total of 70 patients had enrolled for the trial. The participants presented with cervical or thoracic spinal cord injuries and all failed to respond to prior medical treatment. The patients were divided into two groups, one that would only be given physical therapy (control group) and one that would receive both physical and stem cell therapy. The therapy comprised of autologous bone marrow stem cells which were injected near the damaged area. All patients were examined on a monthly basis for 1,5 years using the American Spinal Injury Association Impairment (AIS) Scale, to check for any sensory and motor functions improvements.
As expected, none of the patients in the control group (PT only) showed any improvements. However, many of the patients that received the stem cell therapy responded to tactile and sensory stimuli. After three months, many of them had managed to be catheter-free, sit up, turn in their beds and a few even managed to walk with assistance.
"At 18 months post-treatment, 23 of the 50 cell therapy-treated cases (46 %) showed sustained improvement using AIS.". From the study's abstract
For some reason, the treatment seems to benefit more patients with thoracic spinal cord injuries as they reported greater gains in their motor skills.
"Compared to those patients with cervical injuries, a higher rate of functional improvement was achieved in thoracic SCI patients with shorter durations of injury and smaller cord lesions.". From the study's abstract
It should also be noted that no serious adverse effects were reported by the patients in the stem cell group.
Sabaawy says that the study had mainly one goal, to give patients that had no options left, "some hope", and and it seems that the goal has been fulfilled.
"Although a cure for spinal cord injury does not yet exist, it is clear that the regenerative and secretory properties of bone-marrow derived stem cells can improve symptoms of paralysis in some patients when coupled with the current standard of care that physical therapy provides," said Sabaawy.
The researchers plan to further monitor the patients for any long-term side effects and aim to begin a multicentre international phase two clinical trial in the near future.
A spinal cord injury refers to any injury to the spinal cord caused by trauma. Depending on the location and size of the damaged area the symptoms may vary from pain to severe paralysis.
|View of the vertebral column and spinal cord|
El-Kheir WA, Gabr H, Awad MR, Ghannam O, Barakat Y, Farghali HA, Maadawi ZM, Ewes I, & Sabaawy HE (2013). Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell transplantation PMID: 23452836