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Regenerative medicine is a field of biomedicine where damaged cells, tissue, or organs are replaced to establish or restore normal function. Regenerative approaches are varied and dependent on the therapeutic area. Many therapeutic approaches include the use of human-derived pluripotent stem cells originating from tissue that is inherent or reprogrammed to be pluripotent.

How many people worldwide are diagnosed with a degenerative disease?

Millions of people worldwide are diagnosed with degenerative diseases each year:

  • Chronic Wounds – 6.7 million people
  • Degenerative Disc Diseases – 400 million people
  • Dementia – 50-65 million people worldwide
  • Osteoporosis – 500 million people
  • Parkinson’s Disease – 7-10 million people
  • Schizophrenia – 24 million people worldwide
  • Stroke/Infarction – 100 million people

Clinical Trials for Regenerative Medicine

In 2022,  over 13, 000 publications on PubMed mentioned “regenerative medicine” while only 95 of those publications are results of clinical trials. Most of those studies addressed the restorative effects of stem cell transplantations for treatment of diabetic ulcers, traumatic brain injury, post-chemoradiotherapy, urinary incontinence, stroke, bone fractures, osteoarthritis, Parkinson’s Disease, wound healing, respiratory disorders, and more.

The most commonly developed regenerative therapeutics fall under these top 10 conditions:

  1. Vascular Diseases
  2. Central Nervous System Diseases
  3. Musculoskeletal Disease
  4. Wounds & Injuries
  5. Chronic Graft versus Host Disease
  6. Pain
  7. Bone & Joint Diseases
  8. Endocrine System Disease
  9. Immune System Disease
  10. Rare Genetic Diseases, Inborn 

What are the preclinical challenges of regenerative medicine?

AniLocus wants your company to be listed among the sponsors actively conducting clinical trials. Our CRO insists on conducting relevant preclinical studies that advance your product from bench to market.

Contact us to discuss state-of-the-art preclinical CRO solutions for your drug and medical device development.

Multiple animal models are used in regenerative medicine preclinical product development including:

  • Gene knockout/knockin/trapped
  • Transgenic rodents
  • Chemically-Induced Point Mutation rodents
  • Stress-induced models
  • Drug-Induced models
  • Wound/Laceration Models
  • Metabolically-induced models (Diet-induced, Metabolic disorder, micronutrient deficient)
  • And more…

We conduct translational animal studies (in vivo and in vitro) collecting detailed, comprehensive results with rapid turnaround.

AniLocus provides preclinical CRO solutions for the following therapeutic areas in regenerative medicine:

Neurodegenerative Disorders
Alzheimer’s Disease
Amyotrophic Lateral Sclerosis (ALS)
Anxiety
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorders
Cerebral Stroke/Ischemia
Concussions
Depression
Epilepsy
Huntington’s Disease
Multiple sclerosis (MS)
Olfactory Degeneration/Dysfunction
Parkinson’s Disease
Schizophrenia
Traumatic Brain Injury

Degenerative Joint, Bone and Spine Disease
Diffuse Idiopathic Skeletal Hyperostosis (DISH)
Disc Degeneration
Osteoarthritis
Osteoporosis
Spine Curvatures (Kyphosis, Lordosis, and Scoliosis)
Spondylitis
Stenosis

Degenerative Eye Disorders
Age-related macular degeneration (AMD)
Cataract
Diabetic Retinopathy
Glaucoma

Degenerative Autoimmune Disorders
Autoimmune Motor Neuron Disease (EAMD)
Fibromyalgia/Chronic Fatigue Syndrome (CFS)
Psoriasis/Psoriatic Arthritis
Rheumatoid Arthritis
Systemic Lupus Erythematosus (SLE)
Tourette syndrome

Injury, Wound Healing, and Trauma
Amputation
Chemical Burns & Injury
Chronic Wounds
Necrotizing Tissue
Revascularization
Soft Tissue Injuries
Surgical Wound Healing
Thermal Burns
Tissue Grafts
Ulcerations
Weapon/Battlefield Trauma
Wound Dressings

 

Drug modalities are different types of therapeutic agents. Each drug is a customizable tool designed for therapeutic intervention. The question is…does your product work and is it safe?

At AniLocus, we conduct relevant preclinical studies to assess any drug modality:

  • Antibodies (nanobodies, monoclonal)
  • Gene therapy (CRISPR, TALEN)
  • Viral therapy (adenovirus-AAV, lentivirus)
  • Oligo- and polypeptides (e.g., stapled and modified peptides)
  • Oligo- and polynucleotides (e.g., siRNAs, mRNAs, aptamers)
  • Polyglycosides
  • Macrocyclic molecules
  • Drug conjugates (e.g., antibody–drug conjugates, drug–drug conjugates, fluorescence-labeled drugs)
  • Targeted protein degraders (e.g., proteolysis-targeting chimeras (PROTACs) and molecular glues) that induce a chemical knockdown of proteins
  • Cellular therapies (stem cells, allogenic, autologous)

Using animal and human cells and tissue we can perform multiple interrogative assays depending on therapeutic area and sample type:

  • DNA: Extraction, PCR, ddPCR, qPCR, sequencing, genotyping
  • RNA: Gene expression profiling, RT-PCR, miRNA, Next-generation sequencing (Nanostring, Illumina), spatial transcriptomics, In situ hybridization (ISH), Multiplex ISH
  • Protein: Immunoassays (ELISA, EIA, Luminex), proteomics, ligand binding assays, protein expression, immunohistochemistry (IHC), immunocytochemistry (ICC), and  immunofluorescence (IF)
  • And more!
  1. GBD 2019 Dementia Forecasting Collaborators (2022). Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019. The Lancet. Public health, 7(2), e105–e125..
  2. de Haan P, Klein HC, ‘t Hart BA. Autoimmune Aspects of Neurodegenerative and Psychiatric Diseases: A Template for Innovative Therapy. Front Psychiatry. 2017 Apr 4;8:46. doi: 10.3389/fpsyt.2017.00046. PMID: 28421005; PMCID: PMC5378775.
  3. World Health Organization. Schizophrenia. Newsroom Fact Sheets. Published: 10 January 2022. < https://www.who.int/news-room/fact-sheets/detail/schizophrenia >.
  4. International Osteoporosis Foundation. EPIDEMIOLOGY OF OSTEOPOROSIS AND FRAGILITY FRACTURES. Facts & Statistics. Accessed: 15 Oct 2022. < https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures >.
  5. GBD 2016 Neurology Collaborators (2019). Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet. Neurology, 18(5), 459–480. < https://doi.org/10.1016/S1474-4422(18)30499-X >.
  6. Park, Y. J., Niizuma, K., Mokin, M., Dezawa, M., & Borlongan, C. V. (2020). Cell-Based Therapy for Stroke: Musing With Muse Cells. Stroke, 51(9), 2854–2862. < https://doi.org/10.1161/STROKEAHA.120.030618. >
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