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Below is a list of conditions for which clinical and/or preclinical studies have suggested mesenchymal stem cell treatment may be useful. This list is not comprehensive, but shows the potential that cell therapy holds. Please click on the individual condition for a short summary and links to the studies.

Autism

Clinical trials using mesenchymal stem cells to treat autism have shown promise. A clinical by Lv et al demonstrated improvement in autism patients treated with mesenchymal stem cells. This study treated patients with intravenous and intrathecal stem cells and found improvements in multiple autism specific disease rating scores in comparison to a control group. Another study done by Riordan et al showed improvement with mesenchymal stem cell treatment. This trial saw improvement in clinical rating scores after treatment with intravenous mesenchymal stem cell as well as decrease in inflammatory cytokines. In line with some of this clinical data and clinical trials from other neurologic disease, we believe that intravenous and/ or intrathecal administration of mesenchymal stem cells can be an effective treatment for autism.

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Diabetes

Clinical studies of mesenchymal stem cell treatment in the treatment of type 1 diabetes shown promise. A study done by Hu et. al showed an improvement in DM1 patients treated with intravenous mesenchymal stem cells. This study showed an improvement in HBA1C and C-peptide levels. In line with some of this clinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for DM 1. Mesenchymal stem cells have also shown some efficacy in the treatment of type 2 diabetes. A study done by Jiang et al showed an improvement in DM2 patients treated with intravenous mesenchymal stem cells. This study showed positive results in treated patients with improvements in average blood insulin levels and C-peptide as well as improvements in renal and cardiac function[10].

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Erectile Dysfunction

Clinical studies of mesenchymal stem cell use in the treatment of erectile dysfunction have shown promise. A study done by Protogerous et. al showed an improvement in erectile dysfunction in patients treated with intracavernosal mesenchymal stem cells. This study showed improvement in patient reported outcome scores, penile triplex, and morning erections[1]. Another clinical study by Garber & Carlos showed improvement in rigidity, medication dosage, and blood glucose levels in diabetic patients with erectile dysfunction[2]. In line with these clinical studies, we believe that intravenous and/ or intracavernous administration of mesenchymal stem cells can be an effective treatment for erectile dysfunction.

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Essential Tremor

Degenerative neurologic conditions with motor symptoms have been shown in published literature to respond to mesenchymal stem cell treatment. This has been seen in conditions like amyotrophic lateral sclerosis, multiple system atrophy, and Parkinson’s disease. Patient’s in these studies have shown improvement in movement and clinical outcome scores. In line clinical data from other neurodegenerative diseases, we believe that a combination of intravenous, and/or intrathecal administration of mesenchymal stem cells can be an effective treatment for essential tremor without exposing patients to the risks the direct implantation incurs.

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Fractures

Clinical studies of mesenchymal stem cell treatment in the treatment of bone fracture have shown promise. A study done by Desai et al examined the effect of mesenchymal stem cell treatment on patients with nonunions or delayed union fractures. Using mesenchymal stem cells, this study achieved a 79.6% union rate and demonstrated union rate with an average healing time of 4.7 months. Another clinical study by Centeno et. al found treatment with mesenchymal stem cells improved healing in 4 of 6 patients with long term non-union fractures (up to 18 months of nonunion prior to treatment)[2]. In line with some of the preclinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for thyroid disease.

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Frailty and Chronic Fatigue

Clinical studies of mesenchymal stem cell use in the treatment of frailty and chronic fatigue have shown promise. A study done by Golpanian et. al showed an improvement in both frailty and fatigue in patients treated with intravenous mesenchymal stem cells. This study showed improvement in patients 6 minute walk distance, inflammatory markers, and quality of life. Another clinical study by Tompkins et al also showed showed mesenchymal stem cells to help in the treatment of frailty and chronic fatigue. This randomized, double-blind, placebo controlled trial showed a significant improvement in 6 minute walk test, physical performance, forced expiratory volume, and inflammatory marker in patients treated with mesenchymal stem cells[2]. In line with these clinical studies, we believe that intravenous and/ or intracavernous administration of mesenchymal stem cells can be an effective treatment for erectile dysfunction.

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Inflammatory Bowel Disease

Clinical studies of mesenchymal stem cell treatment in the treatment of inflammatory bowel disease have shown promise. A study done by Hu et. al showed an improvement in ulcerative colitis patients treated with intravenous mesenchymal stem cells compared to a placebo control. This study showed improved IBDQ scores as well as improved Mayo scores and histology scores. Another clinical study by Duijvestein et. al showed some Chron’s patients had an improvement in clinical and endscopic scores after treatment with intravenous mesenchymal stem cells. In addition to systemic administration of mesenchymal stem cells, there is a large body of literature that shows efficacy of intralesional administration of mesenchymal stem cells in Chron’s patients with perianal fistulas. In line with some of the preclinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for Inflammatory bowel disease.

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Interstitial Cystitis

Preclinical studies of mesenchymal stem cell treatment in the treatment of interstitial cystitis have shown promise. A study done by Song et. al showed an improvement in irregular and decreased voiding interval in an preclinical study of interstitial cystitis. The study also showed improvement in denudation of bladder epithelium and mast cell infiltration[9]. Another preclinical study by Ryu et al showed improvement in bladder voiding and histology. In line with preclinical data and clinical data from other inflammatory disorders, we believe that intravenous and/ or pelvic floor administration of mesenchymal stem cells can be an effective treatment for interstitial cystitis.

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Lichen Planus and Planopilaris

Because mesenchymal stem cells have been shown be effective in other inflammatory and autoimmune conditions, they have been proprosed as a treatment for lichen planus/ planopilaris. This rationale behind this also includes the fact that lichen planus is thought to be a t-cell mediated disease and mesenchymal stem cells have shown the ability to regulate T-cells in vitro and in vivo. In line with this rationale and clinical data from other autoimmune conditions, we believe that intravenous and subcutaneous administration of mesenchymal stem cells can be an effective treatment for lichen planus/ planopilaris. .

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Lupus

Clinical studies of mesenchymal stem cell treatment in the treatment of systemic lupus erythematosus have shown promise. A study done by Wang et. al showed an improvement in lupus patients treated with intravenous mesenchymal stem cells. This study showed improved clinical scores as well as improved kidney function markers and decreased anti-neutrophil antibodies and anti-double stranded DNA antibodies. Another clinical study by Liang et. al showed Lupus patients had an improvement in clinical scores and decreased proteinuria and auto-antibodies after treatment with intravenous mesenchymal stem cells. In line with some of this clinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for systemic lupus erythematosus. .

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Minimal Change Nephrotic Syndrome

Conventional treatment of minimal change disease and other autoimmune disease is typically dependent on long term treatment with steroids and immunosuppressive agents. These therapies are often associated with severe side effects and opportunistic infections and vary widely in their effectiveness. Treatment of autoimmune conditions with mesenchymal stem cells represents a potential alternative to these therapies and avoids the side effects associated with conventional treatment. Clinical trials using mesenchymal stem cells have already started showing efficacy in a wide range of autoimmune conditions including rheumatoid arthritis, ankylosing spondylitis, lupus, multiple sclerosis, psoriasis, and inflammatory bowel disease. It has been shown that mesenchymal stem cells treat these autoimmune conditions through a variety of paracrine mechanisms. These include secretion of cytokines such as TGFB, NO, IL6,IL10 and others. These paracrine mechanisms are thought to moderate and sometimes suppress T and B cell proliferation and modulate the body’s natural immune response. In line with some of the preclinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for minimal change disease.

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Myasthenia Gravis

Preclinical studies of mesenchymal stem cell treatment in experimental models of Myasthenia Gravis (MG) have shown promise. An study done by Sudres et. al showed decrease in circulating anti-Acetylcholine receptor antibodys in addition to an increase in expression of acetylcholine receptors in muscles. Another preclinical model by Yu et al also showed decreasing circulating acetylcholine receptor and decreasing lymphocyte proliferation. In line with some of the preclinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for Myasthenia Gravis.

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Multiple Sclerosis and Amyotrophic Lateral Sclerosis

Preclinical animal studies have show that mesenchymal stem cell treatment in experimental models of Multiple Sclerosis (MS) improved clinical symptoms, central nervous system inflammation, and axonal demyelination. Animal models show MSCs effect MS pathology through selective immunosuppressive effects on T-cells, natural killer cells, B-cells and antigen presenting cells. Multiple clinical trials in humans using mesenchymal stem cells for MS and ALS have shown promise. As mentioned above Karussis et al. 2010 showed improvement in expanded disability status scale in a trail of patients that was followed for a minimum of 6 months. This same study also treated ALS patients with mesenchymal stem cells and found stability in clinical rating scores for 6 months in patients that had been previously declining. A study done by Connick et al. demonstrated improvement in multiple visual parameters in pathients with MS involving visual pathways. Another small study by Bonab et al. showed improvement or stabilization in EDSS scores, functional assessment, and MRI lesions. Intrathecal administration of stromal vascular fraction has also been shown to be effective for the treatment of multiple sclerosis. A study done by Stepien et. al showed 18 months of disease progression free survival in a cohort of patients treated with intrathecal stromal vascular fraction. In line with some of the preclinical data and clinical data from other neurodegenerative disease, we believe that a combination of intravenous and intrathecal administration of mesenchymal stem cells can be an effective treatment for Multiple Sclerosis.

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Parkinson’s Disease

Preclinical studies have shown that mesenchymal stem cell treatment inhibits inflammation within the brain and prevents degradation of dopaminergic neurons within the substantia nigra. Although clinicaltrials.gov shows multiple active studies on mesenchymal stem cells, published data on this treatment is limited. So far, published studies do report clinical improvement in Parkinson’s patients, but these studies use direct implantation of mesenchymal stem cells into the subventricular zone. In line with some of the preclinical data and clinical data from other neurodegenerative disease, we believe that a combination of intravenous and intrathecal administration of mesenchymal stem cells can be an effective treatment for Parkinson’s disease without exposing patients to the risks the direct implantation incurs.

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Neuropathy literature review

Preclinical animal studies of mesenchymal stem cell treatment of peripheral neuropathy have shown promise. A study done by Han et al showed that treatment in a preclinical model of peripheral neuropathy showed improvement in nerve conduction velocity, nerve remyelination seen in histology, and increases in pro-angiogenesis gene expression. Another study done by Waterman et. al showed symptomatic improvement in a preclinical model as well as decreasing proinflammatory cytokines.

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Traumatic brain injury

Clinical trials using mesenchymal stem cells to treat traumatic brain injury have shown promise. A clinical by Wang et al demonstrated improvement in traumatic brain injury patients treated with mesenchymal stem cells. When compared to control group, patients in the treatment arm of the study demonstrated improvement in motor ability of upper and lower extremities as well as self care, sphincter control, communication, and social cognition. Another study done by Tian et al showed also showed improvement in consciousness and motor function in patients with subacute traumatic brain injury treated with mesenchymal stem cells. In line with some of this clinical data and clinical trials from other neurologic disease, we believe that intravenous and/ or intrathecal administration of mesenchymal stem cells can be an effective treatment for spinal cord injury.

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Peripheral Vascular Disease

Clinical studies of mesenchymal stem cell use in the treatment of erectile dysfunction have shown promise. A study done by Carstens et. al showed an improvement in peripheral vascular in patients treated with intracavernosal mesenchymal stem cells. This study showed improvement in pain and claudication symptoms, ulcer healing, ankle/ brachial index measurement, and angiographic imaging. Another clinical study by Gupta et. al showed improvement in rest pain, ankle/brachial index, ulcer healing, and amputation rates in a mesenchymal stem cell treatment group versus a placebo control. In line with these clinical studies, we believe that intravenous, subcutaneous, and/or topical administration of mesenchymal stem cells can be an effective treatment for peripheral vascular disease. .

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Peyronie’s disease

Clinical studies of mesenchymal stem cell treatment in the treatment of Peyronie’s disase shown promise. A study done by Zribi et. al showed an improvement in Peyronie’s disease patients treated with intracavernosal mesenchymal stem cells. This study showed improvement in the volume of plaques, curvature, and clinical rating scores. Another clinical study by Lander et. al showed improvement in erectile function, curvature, and reduction in plaque size for patients treated with stromal vascular fraction and shock wave therapy. In line with clinical data and clinical data from other inflammatory disorders, we believe that intravenous and/ or intracavernous administration of mesenchymal stem cells can be an effective treatment for Peyronie’s disease. Our research will provide high quality data to investigate these and other open questions in the field.

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Primary Sclerosing Cholangitis

Primary sclerosing cholangitis (PSC) is an idiopathic condition characterized by inflammation and fibrosis of the intra and extrahepatic billiary tree. Treatment of inflammatory conditions with mesenchymal stem cells represents a potential alternative to traditional medical therapies and avoids the side effects associated with conventional treatment of inflammatory disorders such as steroids. Clinical trials using mesenchymal stem cells have already started showing efficacy in a wide range of inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, lupus, multiple sclerosis, psoriasis, and inflammatory bowel disease. It has been shown that mesenchymal stem cells treat these inflammatory conditions through a variety of paracrine mechanisms. These include secretion of cytokines such as TGFB, NO, IL6,IL10 and others. These paracrine mechanisms are thought to moderate and sometimes suppress T and B cell proliferation and modulate the body’s natural immune response. While data on mesenchymal stem cell treatment of primary sclerosing cholangitis is rare, one study shows promising potential for this treatment. A recent trial by Sugiura et al examined mesenchymal stem cell treatment of PSC in a preclinical study. This study found improvements in bile duct histologic score- including improvements in biliary hyperplasia and peribiliary fibrosis after treatment with mesenenchymal stem cells. This study also showed a decrease in proinflammatory cytokine expression such as CK19 and MMP-9 after treatment. In line with some of this preclinical data and clinical data from other inflammatory conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for primary sclerosing cholangitis.

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Idiopathic Pulmonary Fibrosis

Clinical studies of mesenchymal stem cell treatment in the treatment of pulmonary fibrosis have shown promise. A study done by Ntolios et. al measured progression in idiopathic pulmonary fibrosis patients treated with mesenchymal stem cells This study showed median progression-free survival of 26 months after treatment with mesenchymal stem cells as measured by forced vital capacity and the diffusion capacity for carbon monoxide (DLco).

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Chronic Obstructive Pulmonary Disease

Clinical studies of mesenchymal stem cell treatment in the treatment of chronic obstructive pulmonary disease (COPD) have shown promise. A study done by Bich et. al showed an improvement in pulmonary function tests, number of number of COPD exacerbations, and patient reported outcomes in patients treated with mesenchymal stem cells. Another preclinical study by Stessuk et al also showed improvements in pulmonary function tests and patient reported outcomes.

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Sjogren’s Syndrome

Clinical and preclinical studies of mesenchymal stem cell treatment in the treatment of Sjogren’s syndrome have shown promise. A study done by Xu et. al showed an improvement in salivary gland inflammation and saliva flow rate in their preclinical animal model treated with mesenchymal stem cells. This study then went on to demonstrate in improvement in patient reported clinical scores as well as improvement in an unstimulated salivary flow in a clinical trial with mesenchymal stem cells. Another clinical study by Liu et. al showed Sjogren’s syndrome patients had an improvement in clinical scores and decreased auto-antibodies after treatment with intravenous mesenchymal stem cells. In line with some of this clinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for Sjogren’s syndrome.

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Spinal Cord Injury

Clinical trials using mesenchymal stem cells to treat spinal cord injury have shown promise. A clinical by Park et al demonstrated improvement in spinal cord injury patients treated with mesenchymal stem cells. The study found over half the patients showed motor improvement of the upper extremities. Some patients also demonstrated improved MRIs and ability to perform activities of daily living. Another study done by Dai et al showed improvement with mesenchymal stem cell treatment versus a placebo control group. This trial saw improvement in AIS grade, motor function, light touch, pin prick sensation, and residual urine volume in the experimental group and no improvement in the placebo control group. In line with some of this clinical data and clinical trials from other neurologic disease, we believe that intravenous and/ or intrathecal administration of mesenchymal stem cells can be an effective treatment for spinal cord injury.

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Stroke

Clinical trials using mesenchymal stem cells to treat stroke have shown promise. A study done by Bang et. al treated patients suffering from strokes in the middle cerebral arterial territory. After treatment with mesenchymal stem cells, patients showed improvement in neurologic deficits compared to a standard treatment group[6]. Another study by Sharma et al showed clinical improvements in half of post stroke patients treated with mesenchymal stem cells. They observed increased improvement in younger patients as well as patients within 2 years of their stroke. In line with some of this clinical data and clinical trials from other neurologic disease, we believe that intravenous and/ or intrathecal administration of mesenchymal stem cells can be an effective treatment for spinal cord injury.

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Systemic Sclerosis

Clinical studies of mesenchymal stem cell treatment in the treatment of systemic sclerosis have shown promise. A study done by Guillaume-Jugnot et. al showed an improvement in hand function, quality of life, finger edema, skin sclerosis, and hand motion/ strength in patients treated with digital subcutaneous mesenchymal stem cells[9]. In line with some of this clinical data and clinical data from other autoimmune conditions, we believe that intravenous and subcutaneous administration of mesenchymal stem cells can be an effective treatment for systemic sclerosis.

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Thyroid Disease

Preclinical studies of mesenchymal stem cell treatment in the treatment of autoimmune thyroid disease have shown promise. A study done by Park et al showed improvement in orbital volume and adipogenesis in an preclinical model of graves disease. This study also showed a decrease in circulating pro-inflammatory cytokines like IL-6, TNF alpha, ILF, and GM-CSF. Another clinical study by Ma et. al found improvement throid function tests as well as inflammatory cytokine expression in a preclinical model of autoimmune thyroiditis after treatment with intravenous mesenchymal stem cells. In line with some of the preclinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for thyroid disease.

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