168
10.7.7.1 Bone Regeneration
EnSCs grown on biomimetic gelatin/apatite (Gel/Ap) scaffolds when implanted
onto a critical size calvarial defect in the cranial bone of adult male rats resulted in
significant bone formation and maturation [ 57 ]. The authors suggested the use of
such biodegradable implants with good mechanical properties seeded with EnSCs
as a therapeutic alternative for skeletal reconstructive surgery.
10.7.7.2 Glioma
The promise of EnSC therapy in managing disease models of Glioma has raised a
paradoxical concern with respect to thieranti-angiogenic role in tumor tissues [ 67 ].
A study by Murphy et al. demonstrated the pro-angiogenic role of EnSCs when
administered in a hind limb ischemia model [ 68 ]. Contrary to this finding, when
administered into rat models of Glioma, EnSCs promoted significant inhibition in
tumor angiogenesis. The number of CD 133 positive cells was also observed to be
reduced in the tumor tissue supporting the tumor inhibitory activity of ERCs [ 67 ].
Further studies are however needed to determine the underlying mechanisms by
which the administered EnSCs support an increased physiological angiogenesis as
well as a reduced tumor angiogenesis.
10.8 EnSCs in Clinical Trials: Success Stories
In 2009, Zhong et al. described for the first time production of clinical grade
‘Endometrial Regenerative Cells’ (ERC) for treatment of multiple sclerosis [ 58 ].
Healthy non-smoking female volunteers aged 18–30 years served as endometrial
donors in the study. A small clinical trial was performed wherein patients with mul-
tiple sclerosis were treated intravenously and intrathecally with menstrual blood-
derived EnSCs by administering a series of 3–5 injections with a total dose of 16–30
million cells. The patients were followed for a longer time period, upto an year, for
any immunological or adverse reactions. Results showed no immunological reac-
tions or adverse side effects in all the four patients enrolled in the study suggesting
the potential of EnSCs as a future therapeutic alternative for multiple sclerosis.
The second clinical trial using EnSCs was performed in a 23 year old male with
Duchenne Muscular Dystrophy, a lethal X-linked musculo degenerative condition.
The patient was treated with a dose of 116 million cells intramuscularly and fol-
lowed up for 3 years. There was no adverse reaction reported following EnSC infu-
sion and the patient was in general good health. Increased muscle strength and
decreased respiratory infection was reported in the third year follow up [ 59 , 69 ].
The third clinical report described utilization of EnSCs for ischemic cardiomy-
opathy [ 60 ]. The 74-year old patient, who participated in the study, received a com-
bination of allogeneic CD34 cells and endometrial regenerative cells (ERC) at a
total intravenous dose of 15 million cells over a period of one week. Patient was
K.G. Aghila Rani and T. Madan