ACC and Bone Formation and Regeneration

Amorphical Ltd, an Israeli biotechnology company established on 2004 has developed a unique synthetical production of Amorphous Calcium Carbonate (ACC) based on the natural form found in crayfish known as a gastrolith.

Pre-clinical and clinical studies, conducted by Amorphical, has demonstrated higher bioavailability of the product compared to other products and an increase of bone mass as well as showing muscle improvement.

The bioavailability of the synthetic stable ACC in comparison to the commonly found Crystalline Calcium Carbonate (CCC) was evaluated by Amorphical in a rat radioactive isotope intrinsic labeling model. According to our findings [1] the absorption of calcium from ACC compared to calcium from the commonly found CCC is up to 30% higher, as observed in serum, bone and whole-body retention content. Moreover, an additional clinical study conducted by Amorphical in a cohort of 13 postmenopausal women revealed a 2 fold increase in calcium gastrointestinal bioavailability from synthetic stable ACC compared to CCC [2].

In a following pre-clinical study, we evaluated the effects of both natural (gastrolith) and synthetic stable ACC on bone metabolism of ovariectomized (OVX) rats over a period of 90 days in comparison to the commercially leading brands of CCC and calcium citrate dietary supplements. Our findings, obtained by five distinctive approaches, demonstrated the superiority of natural and in a greater extend synthetic ACC treatments over common marketed calcium supplements in maintaining bone strength and preventing cancellous bone tissue loss [3].

In addition, in an unpublished study done with 13 children aged 8 to 18 years having limb lengthening procedures, we found that bone healing was much faster (30% faster than expected) after these children were treated with only 1/4 of the recommended dose. Also, they started treatment 45 days after surgery because the doctors feared from a too fast healing process.

In Vitro studies performed in-house indicated that treatment of Mesenchymal Stem Cells (MSC) or Osteoblast cells with ACC enhances the proliferation and differentiation of the cells into osteocytes compared to cells with equivalent calcium ions oriented from calcium chloride or regular media with no additional calcium.

Furthermore, previous NASA study has shown that Osteoblast cells had a reduced proliferation rate (60% slower), in space in a microgravity environment in comparison to osteoblast differentiation into osteocytes on earth [4].

Based on our studies and on the NASA study [4], Amorphical performed an experiment to evaluate the potential of ACC as an accelerator of the osteoblast cells’ activity and differentiation into bone cells (Osteocytes) under microgravity conditions, in space. Although the differentiation period in Space was only 2 weeks (in comparison to 3 weeks on earth), the study showed that ACC accelerated the proliferation and differentiation of osteoblasts into osteocytes in space and on earth. The test was performed in comparison to osteoblast differentiation into osteocytes on earth influenced by regular gravitational environment.

These results provide a strong indication that ACC can serve as accelerator of osteoblast cells’ activity and differentiation into bone cells (Osteocytes) both in space and on earth. The enhancement of osteoblast cell activity and differentiation provide further mechanistic evidence for previous observations recorded by Amorphical for enhanced bone growth and repair and prevention of osteoporosis.

References:

1. Meiron, O.E. et al. Solubility and bioavailability of stabilized amorphous calcium carbonate. J Bone Miner Res. 2010; 26: 364-72.
2. Vaisman N. et al. Increased Calcium Absorption From Synthetic Stable Amorphous Calcium Carbonate: Double‐Blind Randomized Crossover Clinical Trial in Postmenopausal Women. J of Bone and Mineral Research. 2014; 29 (10): 2203–2209.
3. Shaltiel1 G. et al. Bone loss prevention in ovariectomized rats using stable amorphous calcium carbonate. Health. 2013; 5 (7A2):18-29.
4. Hughes-Fulford M, Lewis ML. Effects of microgravity on osteoblast growth activation. Exp Cell Res. 1996 Apr 10;224(1):103-9.