Sample of Clinical Evidence for Various Conditions

Sample of Clinical Evidence for Various Conditions

By Adrienne Papp

By Adrienne Papp

“Analysis of different indicators of chronic inflammation and aging included in initial, 24-hours, 2 weeks and 3 months protocols showed that stem cell treatment was safe for the patients; there were no adverse reactions. Moreover, data from follow-up protocols demonstrate significantimprovement in energy level, hair, nail growth and skin conditions… Intravenously administered UC-MSCs were safe and effective in the improvement of symptoms related to chronicinflammation.”

– “Evaluation of immune response to intravenously administered human cord blood stem cells in the treatment of symptoms related to chronic inflammation,” Mehling et al., Journal of Stem Cell Research & Therapy, 2015

“In the MSC-treated joints, there was marked regeneration of the medial meniscus and decreased cartilage destruction and bone changes…”

– “Mesenchymal stem cells in arthritic diseases,” Chen et al, Arthritis Research & Therapy, 2008

Sport Injuries
“MSCs might promote scarless tendon and TBJ (tendon to bone junction) repair via the secretion of a variety of bioactive factors that suppress inflammation, inhibit fibrosis and apoptosis, enhance angiogenesis, and stimulate mitosis and differentiation of host reparative cells.”

– “Stem cell technology for tendon regeneration: current status, challenges, and future research directions,” Liu, Stem Cells and Cloning: Advances and Applications, 2015

“Mesenchymal stem cells (MSCs), derived from the bone marrow, synovium, and even umbilicalcord, play a role as seed cells for the cartilage regeneration of TMJ OA (osteoarthritis).”

-“Mesenchymal Stem Cells for Cartilage Regeneration of TMJ Osteoarthritis,” Cui et al, StemCells International, 2017

“Pooled results from 12 preclinical studies (110 animals in stem cell treatment groups, and 106 animals in control groups) indicated that stem cell based treatment was associated with significantly improved BMD (Bone Mass Density).”

– “Effect of Stem Cell Therapy on Bone Mineral Density: A Meta-Analysis of Preclinical Studies in Animal Models of Osteoporosis,” Li et al, PLOS ONE, 2015

Degenerative Disc Disease
“The results demonstrate the feasibility and safety of the allogeneic MSCs treatment while providing indications for their efficacy for relief of chronic low back pain… The procedure results in significant relief of pain and disability, and quantitative MRI evidence suggests partial disc healing.”

– “Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial,” Noriega et al, Transplantation, 2017

Rheumatoid Arthritis
“Treatment induced a significant remission of disease according to the American College of  Rheumatology improvement criteria, the 28-joint disease activity score, and the Health Assessment Questionnaire. The therapeutic effects maintained for 3–6 months without continuous administration.”

– “Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients with Active Rheumatoid Arthritis: Safety and Efficacy,” Wang et al, Stem Cells and Development, 2013

“Allogeneic UC MSCs (umbilical cord mesenchymal stem cells) were infused intravenously on days 0 and 7… no transplantation-related adverse events were observed. 32.5% patients achieved MCR (major clinical response), 27.5% patients achieved PCR (partial clinical response) during
12 months of follow up.”

– “Umbilical cord mesenchymal stem cell transplantation in active and refractory systemic lupus erythematosus: a multicenter clinical study,” Wang et al, Arthritis Research & Therapy, 2014

Crohn’s Disease
“After UC-MSC (umbilical cord mesenchymal stem cells) infusion, steroid dosage significantly decreased and the patients’ conditions were also improved significantly.”

– “Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn’s Disease: A Randomized Controlled Clinical Trial,” Zhang et al, Gut and Liver, 2018

Ulcerative Colitis
“The use of MSCs can be evaluated as a new strategic direction for therapy UC. MSCs have powerful immunomodulatory effects, reduce the activity of autoimmune inflammation and stimulate the reparative process in the intestinal mucosa, thereby increasing the duration of remission, reduces risk of recurrence of disease, reduces the frequency of hospitalizations.”

– “Allogeneic mesenchymal stromal cells in patients with ulcerative colitis: two years of observation,” Lazebnik et al, Experimental & Clinical Gastroenterology, 2010

“The expression of proinflammatory cytokines such as IL-6, IL-17, and TNF-α was inhibited by MSC injection… Dendritic cells which are co-cultured with MSCs suppressed CD4+ T cell activation and differentiation, which are important for the pathogenesis of psoriasis. These results suggest that MSCs could be useful for treating psoriasis.”

– “Human umbilical cord blood-derived mesenchymal stem cells ameliorate psoriasis-like skin inflammation in mice,” Lee et al, Biochemistry and Biophysics Reports, 2017

“At 6 weeks post-transplant two of four animals responded (decreased rotations by approximately 60%). At 12 weeks’ survival, three of four animals responded to the transplant (decreased rotations by approximately 60%). One animal in the 12-week survival group decreased rotations by 90%. In contrast, the PD (Parkinson’s Disease) animals that were not transplanted with UCMS (Umbilical Cord Matrix Stem) cells all showed a progressive
degradation in performance following 6-OHDA.”

– “Human Umbilical Cord Matrix Stem Cells: Preliminary Characterization and Effect of Transplantation in a Rodent Model of Parkinson’s Disease,” Weiss, Stem Cells, 2006

“Transplantation of stem cells has shown promise for improving functional recovery for Alzheimer’s disease. MSCs could promote survival, increased the metabolic activity and help to rescue the AD (Alzheimer’s Disease) cell model in vitro.”

– “Alzheimer’s Disease and Stem Cell Therapy,” Choi et al, Experimental Neurobiology, 2014

Multiple Sclerosis
“Among the eight cases, six showed therapeutic improvement after hUC-MSCs treatment, and in all eight patients, relapse frequencies decreased to 36.4% of those before the treatment… MRI  characteristics also showed decreased volume and severity of lesions, with few adverse events… hUC-MSCs can alleviate disability and reduce relapse of secondary progressive multiple sclerosis by modulating immune responses, which also had been proved to be safe in MS patients.”

– “Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Secondary Progressive Multiple Sclerosis,” Lu et al, Stem Cell Research & Therapy, 2013

“Recent reports have shown that the administration of stem cells in animals with stroke can induce the reinstatement of functional connectivity, as determined by functional MRI. This, in turn, may be mediated by the outgrowth of nerve fibers of endogenous neurons… Stem cell therapy results in the up-regulation of growth factors that may be responsible for the outgrowth of these endogenous fiber processes and for the inhibition of inflammatory processes, which may lead to secondary cell loss within the brain.”

– “Stem cell therapy in ischemic stroke Role of IV and intra-arterial therapy,” Misra et al, Neurology, 2012

“Treatment of TBI with hMSCs during the acute phase of injury can enhance neurological functional outcome, and suggest that increased levels of neurotrophic factors in the injured hemisphere leading to decreased neuronal apoptosis is one mechanism by which functional recovery may occur.”

– “Therapeutic Effects of Human Mesenchymal Stem Cells on Traumatic Brain Injury in Rats: Secretion of Neurotrophic Factors and Inhibition of Apoptosis,” Kim et al, Journal of Neurotrauma, 2010

Type I Diabetes
“Twenty-nine patients with newly onset T1DM were randomly divided into two groups, patients in group I were treated with (intravenous) WJ-MSCs (Wharton’s Jelly Mesenchymal Stem Cells) and patients in group II were treated with normal saline based on insulin intensive therapy… There were no reported acute or chronic side effects in group I compared with group II, both the HbA1c and C peptide in group I patients were significantly better than either pretherapy values or group II patients.”

– “Long term effects of the implantation of Wharton’s jelly-derived mesenchymal stem cells from the umbilical cord for newly-onset type 1 diabetes mellitus,” Hu et al, Endocrine Journal Advanced Publication, 2012

Type II Diabetes
“WJ-MSC (Wharton’s Jelly MSC) transplantation significantly decreased the levels of glucose and glycated hemoglobin, improved C-peptide levels and beta cell function, and reduced markers of systemic inflammation and T lymphocyte counts… Treatment with WJ-MSCs can improve
metabolic control and beta cell function in patients with T2DM.”

– “A preliminary evaluation of efficacy and safety of Wharton’s jelly mesenchymal stem cell transplantation in patients with type 2 diabetes mellitus,” Liu et al, Stem Cell Research & Therapy, 2014

Heart Disease
HUCB-derived MSCs have been shown to regenerate into cardiomyocytes in vitro… This study supports IV administration as an adequate strategy for HUCB (Human Umbilical Cord Blood) cell transplantation, allowing effective migration of the cells to the area of injury where they subsequently induce autologous differentiation for repair of infarcted myocardium.”

– “Human Umbilical Cord Blood for Transplantation Therapy in Myocardial Infarction,” Acosta et al, Journal of Stem Cell Research & Therapy, 2013

Vascular Disease
“We found a previously unappreciated effect on lipid metabolism. Serum cholesterol was reduced by 33%… MSCs significantly affected lesion development, which was reduced by 33% in the aortic root… We show here for the first time that MSC treatment affects not only inflammatory responses but also significantly reduces dyslipidaemia in mice. This makes MSCs a potent candidate for atherosclerosis therapies.”

– “Mesenchymal Stem Cells Reduce Murine Atherosclerosis Development,” Frodermann et al, Scientific Reports, 2015

Erectile Dysfunction
“Almost all of the studies reported improved erectile function in various animal models of CN (Cavernous Nerve) injury, vascular insufficiency, diabetes mellitus, hyperlipidemia, and aging… a single intracavernous injection of autologous ADSCs (Adipose-Derived Stem Cells) in 17 men (aged 46~69 years) with severe, refractory, post-prostatectomy ED resulting from surgery 5~18 months prior to enrollment…. 8 of the 17 men recovered erectile function with the ability to accomplish sexual intercourse.”

– “The Current Status of Stem-Cell Therapy in Erectile Dysfunction: A Review,” Reed-Maldonado et al, The World Journal of Men’s Health, 2016

Peyronie’s Disease
“In the 5 patients enrolled in the study, statistically significant increases in peak systolic velocity occurred after PM-MSC (Placental Matrix Mesenchymal Stem Cell) injection. Of a total of 10 plaques managed, 7 had disappeared completely at 3-month follow-up.”

– “Effects of Stem Cell Treatment in Human Patients With Peyronie Disease,” Levy et al, The Journal of the American Osteopathic Association, 2015

“A single treatment of hUCB-MSCs (human Umbilcial Cord Blood Mesenchymal Stem Cells) resulted in dose-dependent improvements in AD (Atopic Dermatitis) manifestation. Fifty-five percent of patients in high dose hUCB-MSC-treated group showed a 50% reduction in the EASI (Eczema Area and Severity Index) score… the administration of high dose hUCB-MSCs reduced the pruritus score by 58%.”

– “Clinical Trial of Human Umbilical Cord Blood-Derived Stem Cells for the Treatment of Moderate-to-Severe Atopic Dermatitis: Phase I/IIa Studies,” Kim et al, Stem Cells, 2017

“Autologous cell therapy in patients having chronic obstructive pulmonary disease is a safe procedure and free of adverse effects. There was an improvement in laboratory parameters (spirometry) and a slowing down in the process of pathological degeneration. Also, patients reported improvements in the clinical condition and quality of life.”

– “Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years,” Stessuk et al, Revista Brasileira de Hematologia e Hemoterapia, 2013

“hMSC (human Mesenchymal Stem Cell) infusions decreased ECM (Extracellular Matrix) deposition as evidenced by decreases in soluble and insoluble collagen production… hMSCs participate in improved outcomes of remodeling by reversing excess collagen deposition and changing hyaluronan levels.”

– “Chronic asthma and Mesenchymal stem cells: Hyaluronan and airway remodeling,” Goldstein et al, Journal of Inflammation, 2017

Liver Cirrhosis
“All patients were terminal state LC (Liver Cirrhosis) patients. Two third in 51 had the ascitis and more than one third had hepatic encephalopathy. After single stem cell therapy using  UCBSC (Umbilical Cord Blood Stem Cell), most of the hepatic encephalopathy patients and more than two third of ascitic patients were improved in symptom or responded to medical therapy who were refractory to previous therapy… Stem cell therapy serves for prolongation of the life and improvement of quality of life.”

– “Treatment of the end Stage Liver Cirrhosis by Human Umbilical Cord Blood Stem Cells: Preliminary Results,” Bahk et al, Stem Cells in Clinic and Research, 2011

Kidney failure
“Mesenchymal stem cells (MSC) are significantly renoprotective after ischemia-reperfusion injury… MSC attached in the renal microvascular circulation significantly decreased apoptosis of adjacent cells… These data demonstrate that the unique vasculotropic, paracrine actions elicited
by MSC play a significant renoprotective role after AKI (Acute Kidney Injury)”

– “Vasculotropic, paracrine actions of infused mesenchymal stem cells are important to the recovery from acute kidney injury,” Togel et al, American Journal of Physiology-Renal Physiology, 2007

“The combination of CBMNCs (Cord Blood Mononuclear Cells) and UCMSCs (Umbilical Cord Mesenchymal Stem Cells) showed larger therapeutic effects than the CBMNC transplantation alone… Compared with the Control group, both objective functional and subjective improvements were observed in visual, emotional and intellectual responses, body use, adaption to change, fear or nervousness, nonverbal communication and activity level assessed by CARS (Childhood Autism Rating Scale), as well as in lethargy/social withdrawal, stereotypic behavior, hyperactivity and inappropriate speech evaluated by ABC (Autism Behavior Checklist).”

– “Transplantation of human cord blood mononuclear cells and umbilical cord-derived mesenchymal stem cells in autism,” Lv et al. Journal of Translational Medicine, 2013

Migraines & Tension-Type Headache
“Four women with long histories of migraine or frequent tension-type headache that meet the International Classification of Headache Disorders criteria for Chronic Migraine or Tension-type Headaches… Two of the four patients, both of whom are Arab women aged 40 and 36 years, ceased having migraines after 1 month, for a period of 12 to 18 months. The third patient, a Slavic woman aged 43 years, had a significant decrease in the frequency and severity of migraines with only seven migraines over 18 months. The fourth patient, an Asian woman aged44 years, obtained a temporary decrease for a period of a month and was retreated 18 months later and has been free of migraines to date for 1 month.”

– “Migraine and tension-type headache treated with stromal vascular fraction: a case series,” Bright et al. Journal of Medical Case Reports 2014

“The administration of a single dose of bone marrow- or adipose tissue-derived MSCs reduced continuous chronic alcohol intake by 50% during 10 days… Animals treated with MSCs significantly reduced up to 80–85% their relapse-like alcohol intake compared to control rats… significantly inhibited relapse-like drinking for the 40 days investigated, suggesting a protracted remodeling.”

– “Intracerebral Stem Cell Administration Inhibits Relapse-like Alcohol Drinking in Rats,” Israel et al, Alcohol and Alcoholism, 2017

Hearing loss
“We have restored hearing in 19 years old white female with autoimmune hearing loss with autologous adipose tissue derived stem cells… Systemic infusion of hASCs (human Adipose tissue-derived Stem Cells) (in mouse model) significantly improved hearing function and protected hair cells in established EAHL (Experimental Autoimmune Hearing Loss)… the restoration is due to the paracrine activities of human stem cells, since there are newly regenerated mice spiral ganglion cells, not human mesenchymal stem cells derived tissue given by intraperitoneally.”

– “The paracrine effect of mesenchymal human stem cells restored hearing in β-tubulin induced autoimmune sensorineural hearing loss,” Yoo et al, Hearing Research, 2015

Chronic Pain
“A single systemic injection of hMSCs (human Mesenchymal Stem Cells) into the tail vein was able to reduce NP-like behaviors and to modify molecular and cellular pain-associated pathways… hMSCs were able to reduce pain-like behaviors, such as mechanical allodynia and thermal hyperalgesia, once injected into the tail vein. An anti-nociceptive effect was detectable from day 11 post surgery (7 days post cell injection). hMSCs were mainly able to home in the spinal cord and pre-frontal cortex of neuropathic mice.”

– “Long lasting effects of hMSC systemic administration on pain-like behaviors, cellular & biomolecular modificaiton in neuropathic mice,” Siniscalco et al, Frontiers in Integrative Neuroscience, 2011

Wound Healing
“MSC therapy has shown enhanced wound healing through increased angiogenesis, reepithelialization, and tissue granulation. In clinical settings, MSC also showed a great promise in treating refractory wounds. In clinical studies, after MSC treatment, patients showed improvement of their wounds within days following administration, characterized by a decrease in wound size, an increase in the vascularity of the dermis, and increased dermal thickness of the wound bed.”

– “Advances of Stem Cell Therapeutics in Cutaneous Wound Healing and Regeneration,” Kanji et al, Mediators of Inflammation, 2017

Macular Degeneration
“Animals received syngeneic MSCs (1×106 cells) by tail vein at an age before major photoreceptor loss… both rod and cone photoreceptors were preserved (5–6 cells thick) at the time when control animal has a single layer of photoreceptors remained; Visual function was significantly preserved compared with controls… The number of pathological vascular complexes (abnormal vessels associated with migrating pigment epithelium cells) and area of vascular leakage that would ordinarily develop were dramatically reduced… There was an increase in neurotrophic factors within eyes of animals that received MSCs.”

– “Non-Invasive Stem Cell Therapy in a Rat Model for Retinal Degeneration and Vascular Pathology,” Wang et al, PLOS ONE, 2010

Nerve Injury
“Administration of AFMSCs (Amniotic Fluid-derived Mesenchymal Stem Cells) led to improvements in neurobehavior and expression of regeneration markers. Intravenous administration of AFMSCs may be a promising alternative treatment strategy in peripheral nerve disorder.”

– “Dual regeneration of muscle and nerve by intravenous administration of human amniotic fluid–derived mesenchymal stem cells regulated by  stromal cell–derived factor-1α in a sciatic nerve injury model,” Yang et al, Journal of Neurosurgery, 2012