Pluristem Therapeutics Inc (PSTI)

[FDApproved]

Hi: Voova99...


If You open The PDF Version On The Top Of Page 6:

"However, the pattern of the distribution of regenerating
myofibers, as reflected in fiber diameter distribution, indicated the possibility of a faster regeneration in the cell-treated groups (Figure 4A)."

Page 9:

Discussion:

"This study comprises data related to the first successful use of an allogeneic cell therapeutic approach in patients with skeletal muscle injury. We followed up patients for 2 years after
treatment, and we did not observe any serious product-related side effects. The primary finding of our study was an improvement in muscle strength mirrored by an increase in muscle volume
in the cell-therapy groups compared with the placebo group and an inferiority of the high-dose group versus the low-dose group.

Most striking was the concordance of the results gathered
from the functional assessments and micro- and macro-morphological studies with the immunological analyses."


Page 12:

Furthermore, in depth immunological follow-up analyses revealed the clear dose-dependent effects further supporting the strength of the data despite low number of patients.

Page 13:

In conclusion, our results demonstrate the safety of placental-expanded mesenchymal-like cells for the treatment of iatrogenic muscle injury in patients and provide preliminary results on the
efficacy of this treatment. Our biomarker studies suggest that immunomodulation has a significant impact on regeneration and mediates at least partly the mode of action.


Page 10 Explains Why The Low Dose Performed Better Then The High Dose.

Similar phenomena are seen post-vaccination, particularly with strong adjuvants, and are known as bystander activation. (22) The mechanisms behind bystander activation are the release of “danger” signals in association with cytokines leading to unspecific intra-tissue activation of pre-activated NK- and T-effector cells.

The selected high dose (in the same volume as the low dose, meaning at higher cell concentrations) might have led to critical local conditions for the PLX-PAD cells applied and may be associated with an increased rate of dying PLX-PAD cells that would release danger signals.


https://www.biorxiv.org/content/biorxiv/early/2018/04/16/297739.full.pdf