December 26, 2017

Brain & Neurons

Cerebral Palsy (CP)

Cerebral palsy with a prevalence of 2 per 1000 births is a non-progressive disorder that is associated with the involvement of the central nervous system before, during and after the birth. The main reason of this disorder is lack of oxygen, which affects motor activity, sensation, perception, speech, and the ability to social communicate. In spite of existing treatments such as rehabilitation, botulinum and surgery, these patients do not have been treated till now.

 

Therapeutic steps:

In the first stage patient should examine by specialist and after confirmed the CP symptoms, subsequent examination are done on the patient. For cell therapy, the bone marrow biopsy were taken from patients and CD133 cells is isolated from sample and injected intra-static into spinal cord. These patients were evaluated at intervals of 1,3,6 months after cellular injection in terms of adverse effects, as well as motor and cognitive functional status, with the scales such as GMFM-66, GMFCS, FIM + FAM, Ashworth scale, BBS.

 

Patient’s selection:
In this study, 12 CP patients who have been admitted to Shohadaye Tajrish Hospital from 1390-1393 were selected to enter in clinical trials based on inclusion criteria. This disorder has a definite diagnosis of cerebral palsy and has no pelvic or scoliosis displacement, seizure, history of posterior rhizotomy, Intrathecal baclofen pump, and receiving antispasmodic during the past 6 months.

 

Inclusion criteria

Range of age 4-12 years

Mild to moderate disease

 

Exclusion criteria

Seizure

History of orthopedic surgery

Cardiovascular disease, metabolic disease, other systemic diseases

New cognitive impairments

 

Cell Preparation:

Patients under study in the operating room and under sterile conditions underwent bone marrow aspiration and isolated from the sample from CD133 cells.

Cell injection:

Separated cells are transplanted to the patients via the intrathecal method (inside the spinal cord).

 

Study Description:

This study included two groups of 6 CP patients who were under cell and placebo injection according to above criteria. The main purpose of this study was to evaluate the health of this method within 6 months of injection. There was a re-sampled from bone marrow of these patients and CD133+ cells were intrathecal injected for a second time. Follow up of patients after 6 months showed that the second injection had no side effects and the motor, cognitive and muscular spasticity of the patients improved in patients.

سلول درمانی- بیماری مغز و اعصاب

Changes in scoring results 6 months after cell therapy (P < 0.01, bP < 0.001)

 

In this study, the safety of CD133 + cells re-injection was evaluated 6 months after the first injection. 6 patients of 12 patients who participated in this study, were randomly selected. Blood samples were taken from patients again and CD133 + cells were intrathecal injected for second time. After 6 months follow up of patients, the second injection also had no side effects and the motor, cognitive and muscular spasticity of the patients improved in patients.

 

Patients (before/after)

Assessments 1 2 3 4 5 6
GMFM 23/8/34/48 36/37/49/27 26/64/34/8 18/89/31/28 6/25/13/64 12/8/20/74
GMFSC 4/2 3/2 5/4 5/4 5/4 5/5
FIM+FAM 61/120 57/86 52/92 62/132 64/94 56/75
FIM+FAM 32/66 24/43 23/48 30/40 34/52 27/42

 

Cognitive Part

Ashworth scale 5/3 1/1 2/1 4/2 4/4 3/2
BBS 1/9 1/14 0/2 0/2 0/0 0/1

 

 

Amyotrophic Lateral Sclerosis (ALS):

The Amyotrophic Lateral Sclerosis is a progressive neurodegenerative disease in patients that is associated with the upper stimulus neurons destruction in the brain stem and the lower motorway neurons in the spinal cord. This disorder is progressive and causes severe illness and leads to dead in 3-5 years. In some patients, this disorder begin with motor and muscle atrophy in the organs, while in other patients involved muscle worsening weakness leads to difficulty speaking, swallowing, and eventually breathing. The only known remedy for this disease is Rilozole, which has no significant effect on the improvement of patients. Cell therapy research has the potential to revolutionize the way we treat many conditions, including degenerative diseases for which a few effective treatments currently exist.

 

Therapeutic steps:

In the first stage patient should examine by specialist and after confirmed the ALS symptoms, subsequent examination are done on the patient. In cell therapy process, the patient was under bone marrow biopsy and the mesenchymal stromal cells were isolated and cultured then intrathecal (intra- spinal cord) injected in the brain. The injection of these cells has been reported simple and without any complications.

 

Inclusion criteria:

  • ALS Sporadic
  • Ranging in age of 18-55 years
  • ALS-FRS over 24 years
  • FVC more than 40%

Exit criteria:

  • Familial ALS
  • History of autoimmune disease and other diseases affecting vital organs

 

Study 1

In the case of mesenchymal cell transplantation, ALS patients were studied at Royan Institute in collaboration with Mostafa Khomeini Hospital.

 

Patient’s selection:

In this study, 14 ALS patients who have been admitted in Royan institute were under study. From these patients, 6 patients received intravenous injection and 8 patients received intrathecal injection of mesenchymal stem cell derived adipose tissue.

Cell Preparation:

Patients were subjected to bone marrow aspiration, the cells isolated from sample and cultured.

 

Cell injection:

Mesenchymal cells derived from bone marrow with 2 million cells / kg body weight were injected to 6 patients by intravenous injection and 8 patients were under intrathecal injection.

 

Study Description:

In this study, mesenchymal stem cell derived from adipose tissue of health donors were isolated and injected in two methods. Patients were followed up at intervals of 24 hours, 4,6 and 12 months after injection. The aim of this study was assessing safety of intravenous mesenchymal stromal cells injection and also assessing efficacy of isolated cells transplantation from health donors to improve ALS patients.

stem cell- brain

Fig 1- Changes in ALS-FRS amounts in patients who received intravenous injection

Fig 2- Changes in FVC patients who received intravenous injection

cell therapy- brain disease

Fig 3- Changes in the ALS-FRS amounts in patients who received intrathecal injection