FIELD OF THE INVENTION

The invention relates to the use of umbilical cord blood cells to treat brain damage.

BACKGROUND OF THE INVENTION

Stroke refers generally to any event that blocks or reduces blood supply to all or part of the brain. It is the third leading cause of death and the leading cause of adult disability in the United States. Stroke affects about 750,000 people annually. One third of stroke patients die within the first week after the occurrence of the stroke. Of those that survive, a significant proportion are left with moderate to significant disability, including but not limited to facial, limb or total paralysis.

Various attempts have been made to treat the chronic symptoms associated with stroke. Most recently, G-CSF mobilized peripheral blood cells have been reported to treat acute and chronic stroke symptoms. There still exists a need however for treatment modalities suitable for the population at large, including those subjects for whom autologous mobilized cell therapy may not be appropriate.

SUMMARY OF THE INVENTION

The invention provides in its broadest sense a method for treating brain damage using umbilical cord blood cells. Of particular importance is the treatment of chronic stroke and neurodegenerative disease using umbilical cord blood cells. It has been surprisingly found in accordance with the invention that when umbilical cord blood cells are administered into the brain parenchyma of a chronic stroke subject, at least some of the stroke-related disability experienced by the subject is reversed.

Thus, in one aspect, the invention provides a method for treating a subject having brain tissue damage comprising administering into brain parenchyma of human subject in need thereof an isolated umbilical cord blood cell population enriched in CD34+, CD133+, or CD34+/CD133+ umbilical cord blood cells in an amount effective to treat the brain tissue damage.

In another aspect, the invention provides a method for treating chronic stroke comprising intraparenchymally administering into brain of a human subject who has had a stroke an isolated umbilical cord blood cell population enriched in CD34+, CD133+, or CD34+/CD133+ umbilical cord blood cells in an amount effective to treat the stroke, wherein the isolated population is administered more than 7 days after the stroke. In one embodiment, the population is administered more than 1 month after the stroke. In another embodiment, the population is administered more than 3 months after the stroke. In another embodiment, the population is administered more than 6 months after the stroke. In still another embodiment, the population is administered more than 1 year after the stroke.

In another aspect, the invention provides a method for treating brain tissue damage resulting from traumatic brain injury. More specifically in one embodiment, the invention provides a method for treating brain tissue damage by administering into the brain parenchyma of a subject having brain tissue damage resulting from traumatic brain injury an isolated umbilical cord blood cell population enriched in CD34+, CD133+, or CD34+/CD133+ cells. Such brain damage includes that which exists months (e.g., at least one month) or years after the occurrence of the traumatic brain injury. Accordingly, the subject may be treated (i.e., the cells may be administered to the subject) more than 1 month, more than 3 months, more than 6 months, more than 1 year, or longer, after the occurrence of the traumatic brain injury.

In still another aspect, the invention provides a method for treating a subject having a neurodegenerative disorder comprising intraparenchymally administering into brain of a human subject in need thereof an isolated population enriched in CD34+ or CD133+ umbilical cord blood cells in an amount effective to treat the neurodegenerative disorder. The neurodegenerative disorder may be but is not limited to Parkinson's disease, Alzheimer's disease, multiple sclerosis, Huntington's disease, Pick's disease, cerebellar degeneration, and amyotrophic lateral sclerosis (ALS).

In one embodiment, the isolated population is administered more than 1 month after the occurrence of the brain tissue damage or the earliest observation of such damage. In another embodiment, the isolated population is administered more than 6 months after the occurrence of the brain tissue damage or the earliest observation of such damage. In still another embodiment, the isolated population is administered more than 1 year after the occurrence of the brain tissue damage or the earliest observation of such damage.

Various embodiments apply to the aforementioned aspects and these are recited below.

In one embodiment, the population is enriched in CD34+ umbilical cord blood cells. In a related embodiment, the population comprises mononuclear cells that are at least 75% CD34+, or that are at least 90% CD34+.

In another embodiment, the population is enriched in CD133+ umbilical cord blood cells. In a related embodiment, the population comprises mononuclear cells that are at least 75% CD133+, or that are at least 90% CD133+.

In one embodiment, the population is enriched in CD34+/CD133+ umbilical cord blood cells. In a related embodiment, the population comprises mononuclear cells that are at least 75% CD34+/CD133+, or that are at least 90% CD34+/CD133+.

In one embodiment, the subject is at least 60 years of age.

In one embodiment, at least 2×106cells are administered to the subject. In another embodiment, at least 5×106cells are administered to the subject. And in still another embodiment, at least 8×106cells are administered to the subject.

In one embodiment, the population is administered to three sites along a damaged cortical spinal tract.

In one embodiment, the population is derived from a single cord blood unit. In another embodiment, the population is derived from multiple cord blood units. In related embodiments, the population shares less than 4 out of 6 histocompatibility markers with the subject. In another embodiment, the population shares at least 4 out of 6 histocompatibility markers with the subject.

These and other aspects and embodiments of the invention will be described in greater detail herein.

