Treatment Trials

29 Clinical Trials for Various Conditions

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COMPLETED
Progenitor Cells in Human Esophagus
Description

The purpose of this study is to better understand how esophageal cells change with age.

COMPLETED
Stress and Sugar Synergy
Description

The main objectives of this study are to test the hypotheses that: 1) consumption of beverages sweetened with sucrose will increase risk factors for cardiovascular disease to a greater extent than a naturally-sweetened fruit juice such as orange juice, and 2) chronic psychological stress may augment the adverse metabolic effects of sugar intake. The study intervention consists of 2-week's consumption of 25% of energy as sugar provided either as a sucrose-sweetened beverage or naturally-sweetened orange juice.

RECRUITING
Social Relationships and Accelerated Aging in Hematopoietic Cell Transplant Survivors
Description

This project aims to elucidate the important protective elements of social relationships and identify concrete, modifiable behavioral factors that contribute to biological and phenotypic aging in hematopoietic cell transplantation (HCT) survivors and can be used to develop biologically informed interventions to improve quality of life and prolong the healthspan of individuals with accelerated aging.

TERMINATED
Aging Mammary Stem Cells and Breast Cancer Prevention
Description

To examine whether rapamycin can reduce malignant markers and aberrant mammary stem/progenitor cells (MaSCs) number in surgical specimens

COMPLETED
Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty
Description

This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b study.

Conditions
COMPLETED
AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery
Description

The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.

Conditions
COMPLETED
Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects
Description

By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.

RECRUITING
Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry
Description

The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.

WITHDRAWN
Mesenchymal Stem Cells for Age-Related Frailty
Description

Frailty is a health state related to the aging process in which multiple body systems gradually lose their built-in reserves. It is a medical condition of reduced function in older adults which is associated with increased risks of adverse outcomes such as falls, disability, admission to hospital, or need for long-term care. Currently, there is no specific medical treatment of frailty. Mesenchymal stem cells (MSCs) are undifferentiated cells that self-replicated, and some may change into a particular cell type. These cells go to areas of injury due to signals released by injured cells. Upon reaching, the target tissue, MSCs repair injury by releasing growth factors and immune modulators to assist in the body's repair process. This initial study will assess the practicability of using MSCs for age-related frailty and provide information for planning a future full study of MSCs for maximizing Veteran's functional independence.

Conditions
ACTIVE_NOT_RECRUITING
Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans
Description

Background: The higher death rate from COVID-19 in the older population is associated with low CD8 T cell counts in the blood. Researchers want to learn the status of CD8 T cells specific to SARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify why COVID-19 is particularly lethal in the elderly and help to create an effective vaccine against SARS-CoV-2 in the elderly. Objective: To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in people who have recovered from COVID-19. Eligibility: Maryland residents age 18 and older who have tested positive for and recovered from COVID-19. Design: Participants will be screened by phone. They must be able to provide a copy of their positive COVID-19 test result. Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour. Laboratory tests showing a positive COVID-19 result will be verified. Participants vital signs will be checked. This will include blood pressure, temperature, pulse, and respiration. Height and weight will be measured. Participants will have a medical history and medicine review. They will complete a COVID-19 questionnaire. Participants will have blood drawn. They will give a urine sample. Participants will give a saliva sample. They will rinse their mouth with water. After about 3 minutes, they will let saliva pool in the base of their mouth and then spit into a sterile container. Participants may be asked if they would be willing to return for optional visits at about 4 months and 1 year later. They will repeat the same laboratory sampling performed at the first visit. ...

Conditions
COMPLETED
Cell Signaling and Resistance to Oxidative Stress: Effects of Aging and Exercise
Description

Advanced age is the main risk factor for chronic diseases such as cardiovascular disease, type 2 diabetes, Alzheimer's disease and cancer. One reason may be due to decreased resistance to oxidative stress as antioxidant defenses and cell protection is reduced with aging. This has been shown in animal studies and also that the impairment can be somewhat restored with exercise. This will be the first study to test this in humans by comparing young and older inactive adults before and after an exercise intervention, a practical and cost-effective intervention that can have tremendous public health impact by lowering risk for disease and medical-related costs.

Conditions
COMPLETED
Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing
Description

Background: Cellular senescence is the aging of cells. It is a complex process that may be connected with aging and age-related diseases. It is unknown if these cells appear around wound sites in humans a few days after skin injury and if there are differences in young and old individuals. This study is being done to look at how cells in your body respond to small skin wounds. This information may help treat age-related diseases. Objective: To study how cells in the body respond to small skin wounds. Eligibility: Healthy adults ages 20-39 or 70+ Design: Participants will be screened with medical history, physical exam, and blood sample. They will fast before the screening visit. Women will have a urine pregnancy test. Participants will have 3 study visits over about 3 weeks. Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed. Two small pieces of skin will be removed. They will keep the area covered until the next visit. Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be measured and photographed.

WITHDRAWN
Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
Description

Men who present with erectile dysfunction as defined as an IIEF (International Index of Erectile Function) score less than 21 will be evaluated for risk factors for cardiovascular disease (CVD). This is a single-blind study. Subjects will be randomized in a 2:1 fashion for treatment (ARM 1) versus placebo (ARM 2). Adipose tissue (fat) will be harvested from all patients and stem cells will be cultured. For those patients in the placebo arm the stem cells will be frozen for later use after one year when the patients cross over into the treatment arm.

COMPLETED
UCSD Q10 and Aging Study
Description

Goal: The investigators propose to test the feasibility of giving the supplement coenzyme Q10 (Q10) improves symptoms and subjective health in an aging population. Rationale: Direct empirical evidence has supported benefit of Q10 to many symptoms such as fatigue, muscle pain, and cognition. In addition, Q10 has also been reported to benefit other symptoms including headaches, sleep disturbances, and breathing problems. This provides a strong rationale for testing whether Q10 will have similar benefit to these symptoms in an aging population. Method: 44 aging subjects will participate. The design is a 9 month, randomized, double-blind, placebo-controlled crossover study. Each subject will be "crossed over" between high dose Q10 (300mg), low dose Q10 (100mg), and placebo, receiving each agent for 3 month periods. Neither subjects nor investigators will know which substance each subject is receiving in which phase. Subjects will be randomly assigned to one of six arms. Assessments: Assessments will include feasibility of study, subjective quality of life, energy, and metabolic and lipid panels. Analyses will show whether Q10 led to improvements when compared to placebo; whether higher Q10 doses improved outcomes more than lower doses; and whether people with certain symptoms or characteristics get more benefit than people with other symptoms or characteristics.

COMPLETED
Exercise and NutraStem (NT-020): Effects on Stem Cells
Description

The purpose of this study is to see if an investigational supplement called NutraStem® will increase the amount of stem cells in human blood at rest and after exercise. The ingredients found in NutraStem® can be found in nutrition or vitamin shops/stores.

COMPLETED
Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells
Description

The primary purpose of this study is to demonstrate the safety of injecting the Stromal Vascular Fraction (SVF) \[containing Adipose Derived Stem Cells (ADSCs)\] enriched fat grafts into regions of the face that require enhancement. The safety of SVF will be evaluated throughout the course of the study phase through the assessment of laboratory values, physical examinations, adverse events, safety phone calls etc.

ACTIVE_NOT_RECRUITING
Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
Description

The purpose of this study is to determine whether a one-time injection of allogeneic mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the face.

COMPLETED
Regulation of Endothelial Progenitor Cells by Short-Term Exercise
Description

Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are important for maintaining cardiovascular health. The prevalence of cardiovascular disease in older adults is associated with reduced circulating EPC numbers. Studies have shown reduced EPC number and function in old vs. young individuals, and endurance exercise training increases EPC number and function in young adults. Oxidative stress adversely affects endothelial cells and preliminary evidence indicates that oxidative stress negatively affects EPC function. Conversely, regular exercise reduces markers of oxidative stress and may enhance EPC function in older adults. The investigators hypothesize that older endurance-trained athletes and matched sedentary individuals will have markedly divergent EPC function and that altering the physical activity levels of both groups will move them to intermediate points between these two extremes. The investigators also propose that the investigators can "mimic" the effect of exercise training on EPC function in cell culture by altering intracellular levels of a key enzyme and a signaling molecule which the investigators have shown to regulate EPC function with respect to exercise training in young individuals.

COMPLETED
B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging
Description

B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for \~25% of all leukemia's (1). This disease occurs virtually exclusively in the aging population, with the median age of diagnosis ranging between the mid 60s and the early 70s. Indeed, its occurrence before the age of 50 is quite unusual. This increase in occurrence with age is not unique to B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g., non-Hodgkin's lymphoma, multiple myeloma). Gender and race also influence the development of B-CLL. Thus, the ratio of men: women is \~2:1 and the prevalence is increased in Caucasians. The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and this does not increase with immigration to the West. DNA sequence analyses performed in our laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig V gene characteristics. These include the use of selected genes, the association of these genes with certain D and JH gene segments that code for unique CDR3 motifs, and the occasional occurrence of highly similar VHDJH + VLJL pairs. In \~50% cases, these rearranged genes are mutated, whereas in the others mutations are infrequent; this difference is related to the VH gene family used by the B-CLL cell.

COMPLETED
Relationship Between Physical Activity and Stem Cells in Older Adults
Description

This is a pilot study to develop a collaborative, translational research project investigating whether physical activity may in part exert a positive influence on aging via the mobilization of stem cells. Preliminary data will be collected to explore the relationship between physical activity and stem cell populations found in the blood. The study hypothesis is that stem cell decrease with age, but that persons who are more physically active will have a higher number of stem cells in the blood. The first assessment will include an evaluation of health, physical activity and lifestyle via questionnaires. Height, weight and abdominal girth will be measured, and blood will be drawn for immune and stem cell assessment. Participants will be given a pedometer and accelerometer to wear daily for 7 days. Participants will return for a second visit at which the pedometer and accelerometer will be returned and blood will be drawn. Stem cell and immune assays will be repeated to evaluate the variability of these measures over time. The correlation between stem cell numbers and physical activity will be analyzed.

Conditions
RECRUITING
Western Diet on Cardiometabolic and Immune Function
Description

This study will implement a Western Diet (WD) to understand cardiometabolic and immune function in middle-aged adults (50- 64 years old). Vascular health, intestinal permeability, and T-cell function will be examined before, during, and after the WD. The WD is a 10-day diet and will consist of 25% of total energy from added sugars.

RECRUITING
A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults
Description

This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally follow a cohort of 75 older adults (65 years and older) who will receive three different influenza vaccines over three annual influenza seasons. Blood samples will be collected from the participants at sixteen study visits over three years. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.

RECRUITING
Collection of Bone Marrow Aspirate From Normal Volunteers
Description

Background: Bone marrow is the soft material found inside most large bones of the body. Bone marrow produces red blood cells, white blood cells, and platelets that are released into the blood stream. Inside the marrow, these cells start off as young, immature cells called progenitor cells. Researchers want to study these cells in healthy people. Objective: To understand how progenitor cells change with age. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a questionnaire, a physical exam, and blood tests. Participants will have a bone marrow aspirate. They will be asked to lie on their stomach or side. A local anesthetic will be injected with a small needle under the skin at the site. A needle will then be placed through the skin and into the hip bone. A small amount of the liquid part of the bone marrow will be taken up into the needle. After the needle is removed, a pressure bandage will be placed on the site. Participants will be asked to become a repeat volunteer and have a bone marrow aspirate sample collected once every other year. They will have a physical exam and blood tests before each collection. The cells from the collection will be used for genetic testing and research. Participants will be in the study for as long as they remain healthy and willing to participate.

Conditions
COMPLETED
A Comparative Study of Subjects Past Their Final Follow-ON Visit
Description

A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.

RECRUITING
A Novel Approach Utilizing Organ Specific Age Proteomics
Description

This study compares changes in P16INK4A expression and plasma proteomic signatures of specific organ age pre- and post-chemotherapy in women treated with adjuvant chemotherapy for early-stage breast cancer. It aims to determine if biological and accelerated immune aging, assessed using T cells from peripheral blood, represents aging in different organs. Patients receiving chemotherapy, especially adjuvant regimens that include anthracyclines and taxanes, often experience late development of cardiac toxicity, functional loss, and cognitive decline. Comparing baseline characteristics with organ aging before therapy might identify patients at the highest risk for chemotherapy complications. For example, this is clinically significant for patients whose therapy includes taxanes or other drugs known to cause peripheral neuropathy. Identifying aging in the neurological or vascular systems before treatment might lead to changes in regimens. Determining accelerated aging in specific organs allows for investigating interventions to mitigate organ damage. For instance, identifying patients at the highest risk of cardiac aging after treatment could lead to testing the effects of exercise, senolytics, and other strategies to reduce the risk of long-term heart disease.

Conditions
COMPLETED
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss
Description

To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting hair growth as assessed by change in hair density and percentage of terminal hair regrowth after ALRV5XR therapy. This will be a single-centre, double-blind, randomized, placebo-controlled study in female subjects randomized to a 1:1 ratio of test article to placebo. Subjects will be asked to use the study products on a daily basis for the duration of the 24-week study. Subjects will take one capsule twice daily (one in the morning and one in the evening) and will be asked to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment daily. Subjects will receive detailed instructions regarding the order and duration of application of each product. Subjects in the active arm will receive active capsules, shampoo, conditioner and topical nutriment. Subjects on placebo will receive placebo capsules, shampoo, conditioner and topical nutriment. All subjects will be instructed to take the capsules orally, one in the morning and one in the evening, prior to consuming food. Shampoo and conditioner are to be used once per day when washing the hair and nutriment applied at the end of the day prior to bedtime. To facilitate this, subjects will receive a 3-month supply of each product (supplement, shampoo, conditioner, and scalp nutriment). Subjects will continue the daily regimen for 24 weeks, visiting the clinic at week 12 for an interim assessment.

COMPLETED
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss
Description

To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting hair growth as assessed by change in hair density and percentage of terminal hair regrowth after ALRV5XR therapy. This will be a single-centre, double-blind, randomized, placebo-controlled study in male subjects randomized to a 1:1 ratio of test article to placebo. Subjects will be asked to use the study products on a daily basis for the duration of the 24-week study. Subjects will take one capsule twice daily (one in the morning and one in the evening) and will be asked to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment daily. Subjects will receive detailed instructions regarding the order and duration of application of each product. Subjects in the active arm will receive active capsules, shampoo, conditioner and topical nutriment. Subjects on placebo will receive placebo capsules, shampoo, conditioner and topical nutriment. All subjects will be instructed to take the capsules orally, one in the morning and one in the evening, prior to consuming food. Shampoo and conditioner are to be used once per day when washing the hair and nutriment applied at the end of the day prior to bedtime. To facilitate this, subjects will receive a 3-month supply of each product (supplement, shampoo, conditioner, and scalp nutriment). Subjects will continue the daily regimen for 24 weeks, visiting the clinic at week 12 for an interim assessment.

COMPLETED
Autophagy Maintains Vascular Function Through a Novel Glycolysis-linked Pathway Regulating eNOS
Description

Aging is inevitable and is the primary risk factor for developing cardiovascular disease. The molecular mechanisms that drive vascular dysfunction in the context of aging are incompletely understood. The overall hypothesis is that the age-related decline in endothelial cell (EC) autophagy leads to arterial dysfunction. This study will determine whether physiological shear-stress affects autophagosome formation and nitrous oxide (NO) generation in ECs.

COMPLETED
Resveratrol to Enhance Vitality and Vigor in Elders
Description

Resveratrol, a compound found in red wine and dark-skinned grapes, will improve the function of mitochondria (energy producing components) within the leg muscles of moderate functioning older adults. The investigators will look at the role Resveratrol plays in improving physical function by studying the connection of changes in mitochondrial function and changes in physical function.