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the science- SERTOLI CEll TRANSPLANTATION

The Science

 

Sertoli Cell Transplantation

Sertoli Cells (SC) have been recognized to play an important role at different levels, including regulation of synthesis of androgen binding protein and the paracrine action on peritubular and Leydig cells. In addition, SCs provide an appropriate microenvironment for the development of germ cells, while recent reports have shown that these cells provide nutrients and immune-modulatory and trophic factors that are able to ameliorate survival and development of different cell types and to improve their functional competence.

 

In Type 1 Diabetes (T1D) murine models, SCs protected co-grafted allogeneic and xenogeneic islets from immune destruction. Hence, SCs might confer the transplanted islets immune-protection, thus representing a possible approach to overcome a major obstacle associated with cell therapy.

 

Altucell’s team has recently demonstrated that SCs, enveloped in barium alginate-based microcapsules and transplanted in peritoneal cavity of pre-diabetic and diabetic NOD’s, can prevent/or reverse T1D, based on SCs powerful immune-modulatory effects and ß-cell regeneration properties.

Microencapsulated Sertoli cells represent a new approach

to cell and molecular therapy of T1D and other

autoimmune and neurodegenerative diseases.

Because transplanted “naked” SCs would be impossible to retrieve, thereby disregarding an important regulatory issue (as per FDA’s guidelines), Altucell has employed its patented technology for fabrication of ultrapure alginate-based microcapsules to envelop pure populations of isolated pre-pubertal pig SCs.

 

Microencapsulation features and benefits

 

1. Microcapsules are gel microspheres that serve for micro-containers of a variety of cells. Highly specialized cells, such as pancreatic islet beta cells secreting insulin, may be encapsulated with full retention of the entrapped cells viability and function. When containing secretory cells, the microcapsules constitute a bio-hybrid organ for bioactive molecules delivery.

2. Microcapsules are fabricated with ultra-purified ("clinical grade") alginic acid polymers that comply with FDA specifications for human use. In fact, these capsules are highly biocompatible, selectively permeable and retrievable upon graft. 

3. Microcapsules formulated with ultra-purified alginates and poly-L-ornithine have reached the standards (permission obtained from European and Italian Agency for Drugs) for use in patients with type 1 diabetes: 4 transplanted human patients with long standing T1D have shown evidence of grafted encapsulated islet cells function throughout 5 years of post-transplant follow-up.

4. Depending upon the cell types that are lodged within microcapsules, the microencapsulated cells have been proven effective not only in the treatment of T1D, but also of other chronic diseases, including neurodegenerative (muscular dystrophy, Parkinson’s, Huntington’s, etc.) and auto immune conditions (rheumatoid arthritis, psoriasis, multiple sclerosis, etc.). 

5. The microcapsules have been shown to clearly prolong the life span of the encapsulated cells and are suitable for long-haul transportation with no loss of cell viability. These microcapsules are very easy to handle and transplant: easily injectable in the peritoneal cavity under local anesthesia.
 

                                                                                                           Altucell Therapeutics