October 25, 2010
A Study of Safety/Efficacy of Bone-Marrow Derived Adult Stem Cells in Patients with Amyotrophic Lateral Sclerosis
Description
A Phase I, single center, prospective, non-randomized, open label, safety/efficacy study of the infusion of expanded autologous (from the same person) bone-marrow derived mesenchymal (adult) stem cells. A bone marrow aspiration from the hip is performed. The adult stem cells are separated from the bone marrow and expanded in an incubator for approximately three weeks. The cells are suspended in fluid and injected using a lumbar puncture (similar to a spinal tap). The patients will be followed at routine intervals for one year.
Subject Size: Six subjects are required
Status: Currently Recruiting
Primary Outcome: Safety with no complications or new neurological deficits
Secondary Outcomes: Slowing of decline as rated by vital capacity (ability to breathe) and function
Inclusion Criteria:
Males and females 18 years or older
Moderate to severe diagnosis of ALS
Vital capacity at least 50%
ALS Diagnosis greater than six months and less than 36 months
Exclusion Criteria:
Illness or medications that affect bone marrow
Riluzole within 4 weeks of study entry or during the study
Bleeding disorders
Current smoker
Contact Information:
Erica Morel RN or Vicki Nicely
(985) 867-4860
www.tcacellulartherapy.com
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