In a recent study of current clinical trials using stem cells, 372 current trials were identified (Bersenev Alexey. Cell therapy clinical trials – 2014 report. CellTrials blog. January 22, 2015. Available:http://celltrials.info/2015/01/22/2014-report/).

The following is a summary of findings relevant to TriStem:

Donor Type

TriStem’s stem cells are created from white blood cells harvested from the patient themselves, this is termed an autologous donor.

TriStem has completed two clinical studies in diseases of the bone marrow. A third study in liver disease as a result of viral infection is currently underway. All three of these use autologous donors.

A clinical study in an inherited blood disorder is being planned using a separate donor to provide the white blood cells, this is called an allogeneic donor.

Donor Type (%)

  • Autologous
  • Allogenic
  • Autologous & Allogenic
  • Unknown

The majority of stem cell clinical trials are being performed using autologous cells. We believe this reflects the two issues of sourcing suitably tissue matched donors, and the subsequent chemo therapy required to suppress the immune system and prevent rejection.

Indications

Indication (%)

  • Cancer
  • Neurology
  • Musculoskeletal
  • Cardiovascular
  • Skin Disease
  • Liver Disease
  • Eye Disease
  • Infertility
  • Pulmonary
  • Viral Infections
  • Diabetes
  • Other

Cancer is the largest indication for current stem cell clinical research. This is not surprising as stem cell transplant has been long established in malignancies of the blood system, replacing diseased bone marrow with donor marrow. The chart also demonstrates the wide interest in treating many diseases with stem cells.

TriStem has patented the use of its stem cells in the treatment of a wide range of diseases.

The cells of the invention are for use in the treatment of a disease selected from bone marrow failure, haematological conditions, aplastic anaemia, beta-thalassemia, diabetes, motor neurone disease, Parkinson’s disease, spinal cord injury, muscular dystrophy, kidney disease, multiple sclerosis, congestive heart failure, hepatitis C virus, human immunodeficiency virus, head trauma, spinal cord injuries, lung disease, depression, non-obstructive azoospermia, andropause, menopause and infertility, rejuvenation, scleroderma ulcers, psoriasis, wrinkles, liver cirrhosis, autoimmune disease, alopecia, retinitis pigmentosa, crystalline dystrophy/blindness, diabetes, and infertility. Hence, in some embodiments, the reprogrammed cells may be bone marrow cells that treat aplastic anaemia, leukaemia, lymphoma, or human immunodeficiency virus in the patient.

You can access the granted UK patent here.

Patients Treated

Autologous Treatment Number of Patients
Multiple Sclerosis 57
Rejuvenation 43
Thalassaemia 36
Diabetes Type 2 30
Kidney Failure 24
Spinal Cord Injury 19
Muscular  Dystrophy 18
Liver Failure 16
Motor Neuron Disease 15
Diabetes Type 1 13
Brain Trauma/Injury/Stroke 12
Cerebal Palsy 11
Aplastic Anaemia 10
Hepatitis C+ 10
Other Indications 73
Total 386

A total of 390 patients have now received treatment and 415 procedures have been performed as at the end of May 2016; the table below summarises the total number of patients treated by indication as part of the Proof of Principle Study, Clinical Study and as Commercial Patients (Fee Paying) using TriStem’s Autologous and Allogeneic Retrodifferentiated Stem Cell Technology.

Allogeneic Treatment Number of Patients
Muscular Dystrophy 2
Sickle Cell Anaemia 1
Epidermolysis Bullosa Dystrophica 1
Total 4

 

 Total Autologous and Allogeneic  390