TCA Cellular Therapy, LLC

This study is based on preclinical (animal) studies showing that infusing bone marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function in animal models with spinal cord injuries. Bone marrow (BM) contains several types of stem cells that can produce functional cells. This includes cells that could help the healing process of damaged neurologic tissue.
The primary objective of this study is to see if the injection of these cells, obtained from your own bone marrow, is safe. A secondary objective is to evaluate if the treatment can provide functional improvements (neuromuscular control and sensation) in the affected areas.

A Phase I, single center, prospective, non-randomized, open label, safety/efficacy study of the infusion of autologous bone marrow-derived stem cells, in 6 patients with Amyotrophic Lateral Sclerosis according to established criteria (1), (2) with a moderate to severe diagnosis of ALS according to the World Federation of Neurology El Escorial criteria.
The primary purpose of this study is to evaluate safety of the infusion procedure, as assessed by absence of complications at the site of infusion or the appearance of new neurologic deficit not attributed to the natural progression of the disease.
Secondary outcomes will include a)neurological evidence of trends toward a slowing down of the decline of the forced vital capacity (FVC) (3) and of the functional rating scale (ALS-FRS) scores, as assessed at 3-month intervals, b)evidence of a decline of the maximum voluntary isometric contraction-arm (MVIC-arm) and MVIC-grip Z (4) scores and c)patient evaluation that the treatment was effective and consider the possibility of a new cell product stem cell infusion.
Subjects who fulfill inclusion/exclusion criteria and sign informed consent will undergo an aspiration of bone marrow from the iliac crest for preparation of the cellular product.
The day of infusion, the investigational product will be injected into the patient's intrathecal space.
After cell infusion patients will be followed at WK 2, MN 1, MN 2, MN 6 and a long-term followup at MN 12 in the clinic and/or office. Electromyographic (EMG) studies, Forced vital capacity (FVC), functional rating scale (FRS) and maximum voluntary isometric contraction-arm (MVIC-arm) and MVIC-grip Z scores will have been used to assess the status of the disease before (historical record acceptable if done within three months of Screening Visit) and during the 12-month study period after cell infusion.

The present investigation will be a Phase II, single center, placebo-controlled, randomized, dose escalation, infusion modality (intracoronary vs transendocardial injection using the Cordis Biosense NOGASTAR TM Mapping Catheter with the Biosense MYOSTAR TM left ventricular injection catheter) transplantation of an autologous (your own stem cells) combination of bone marrow-derived stem cells into myocardium for the treatment of severe coronary ischemia.
The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia(CI).
In this trial we will determine whether the combination stem cell treatment is safe, feasible and results in the development of mature stable and/or collateral vessels and improvement of cardiac function.
Coronary Ischemia (CI) is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart.
CI needs a comprehensive treatment since the condition will not improve on its own. The overall goal of the treatment is to increase blood flow to the heart and improve symptoms of angina.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the heart.
Patients eligible to participate in this study are those suffering from severe blockages of the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures.