Rationale/ Current Status/ Future – SCR

Mothercell – Rationale/ Current Status/ Future

Preclinical results suggest that bone marrow cells may provide a source of stem cells with a potential for migration into inflamed CNS and differentiate into cells expressing neuronal and glial cell markers b islets, hepatocytes etc. Several published studies that have documented the positive clinical effect of delivering bone marrow mononuclear cells. Our own results of pilot human studies are encouraging Based on these available data, we are currently offering a safe and similar therapeutic approach in a small group of patients with various neurodegenerative diseases, hepatic and pancreatic disorders.

Probable mechanism:

In sub acute phase it is possible to prevent further ongoing damage to nerve along with Rejuvenation of normal axons back to function by natural growth factors injected along with stem cells. Stem cells also help by secreting these factors after implantation. Bone marrow derived MSCs have enormous remyelination potential which is a phenomenon of covering nude but intact axons. Once covered these axons start working. Some of these cells also turn into helper cells so that non- functional but intact axons start functioning. In long term sitting few of these stem cells may become neurons and form connections too.In chronic phase though all is not lost but scarred and degenerated nerve becomes a greater challenge.

Current Status

Autologous stem cells have advantage in terms of immune compatibility and ethical issues.

Two major lines of investigation have emerged –one advocating stem cell enrichment only and the other doing expansion with or without differentiating these endogenous stem cells.

Culture of stem cells though increases the number but there are concerns of induction of mutations, change the behaviour of cells etc.

Enrichment has the advantage of fresh cells along with cocktail of numerous different types of supportive cells and growth factors necessary for promoting cell growth.

Though stem-cell therapy could fundamentally change medicine, almost all treatments being developed were still in an experimental stage or under clinical trial, except for bone marrow transplants.

Clinical stem cell application should be done as a trial in those conditions where scientific evidence in literature is available. It should be carried as clinical trial in few patients (max 20) in which sound preclinical data exists .once the results are encouraging. It should be published followed by a placebo controlled clinical trial on more number of patients … If the individual or centre wishes can apply for patent for future monetary gains.  Any centre claiming of doing hundreds of cases in a particular disease is nonsense.

Stem cell research and therapy should not be hyped but presented as a possible hope.

Many hospitals and centers have overstated their stem-cell treatments with very bold claims.

Don’t be carried away with Testimonials as it can be generated Fake. Understand the Science and if willing kindly participate in it as an experiment.

The field needs time to grow and mature, before stem cells can be turned into clinical and other applications. It will happen, but not right away.”

Patient Education

Allogenic cells (not from Patient’s own tissue) should not come to even clinical trial without preclinical and phase 1 study.

Ficoll- ficoll plus. Lymphoprep, ficoll premium) for mesenchymal stem cell isolation from bone marrow aspirate is not recommended for any clinical use.

  • Cells leave there biological environment.
  • Leads to loss of  not only Mesenchymal cells but also VSELS
  • Does not keeps the charcterstics of these stem cells intact.
  • Though may not  kill these cells but greatly influences their functionalcharcterstics.
  • Not  rich  in neurotrophic growth factors neseccary for stem cells to home at lesion.
  • No studies or data available for safey of ficoll  –biological  effects n cells cell aging damage in the genome (genotoxic ), changes in chromatin structure . Possibility of mutations and late tumor formation.
  • Further it has been shown earlier that CFU (a way of assessment of functional efficacy) is even poorer then native bone marrow.

Avoid use of Cryo preserved cells as much as possible as on thawing viability is lost up to 25 %. There death further increases during transportation. The biological behavior also deteriorates. Ideal is fresh expanded cells directly from Lab.

Route of administration should be as Direct as possible. (Intralesional, feeding artery of the organ involved)

On administering Intravenous- majority of these cells will not reach target, so needs high dose and multiple administration are needed.

In nutshell a patient should understand

  • quantity of cells being injected.
  • Type of cells:  Stem cells are identified by markers. E.g. haematopoietic (CD34 +ve) or mesenchymal (Cd 34 –Ve, CD 105 +ve)

It would be very appropriate for a centre to provide sample of the cells for cross verification.