Phase I/II clinical trials have investigated the benefits of stem cell therapy for chronic paraplegia (spinal cord injury), using a drug manufactured with patients’ own stem cells.
The trials were conducted at Puerta de Hierro Hospital in Madrid on 12 patients, using the new NC1 drug created by DR. Jesús Vallejo. The patients were administered doses of NC1 – made from autologous mesenchymal stromal cells (MSCs) and autologous plasma. The aim was to offer each patient a personalised form of therapy using their own stem cells, by evaluating the characteristics of the spinal cord injury via MRI scan. The MRI determined the amount of NC1 required by the patients.
Before NC1 transplantation, a sample of peripheral blood was taken from each patient to rule out the possibility of chromosomal abnormalities that could interfere with stem cell expansion. Then MSCs were extracted from the patients, cultured, mixed with blood plasma and finally injected into the spinal cord. Additional doses of MSCs were administered 3 months later, with results evaluated 3, 6, 9 and 12 months after surgery.
One participant in the clinical trials was David Serrano, who suffered a spinal cord injury 17 years ago that left him in a wheelchair. After taking part in the first phase of treatment, David started to notice improvements in blood flow and sensitivity in his legs. 12 months later, he can walk and even ride a bike.
David’s case was exceptional, however all 12 patients experienced improvements in general sensitivity. Results revealed that over 50% of the patients showed greater motor activity, decreases in spasms and improved sexual function. Researchers also concluded that these results seemed to be dependent on the dosage of stem cells, and were not influenced by the seriousness of the spinal cord injury.
Since the conclusion of this successful clinical trial, Puerta de Hierro Hospital has announced the approval of the NC1 drug by the Spanish Agency of Medicines. It’s been advised that to be treated, you must be an adult aged 18-65 years old with a chronic spinal cord injury and no chromosomal alterations.
Juan Carvajal, a paraplegia patient, has encouraging words for anyone thinking of trying the therapy:
I would tell these patients not to doubt it, not to think about it, not to delay, the treatment is done with our own cells so there is no rejection and the result is immediate, it is for improvement, the improvement is physical. We are in good hands, mentally and morally
– Juan Carvajal, SCI patient