Stem Cells in Ophthalmology Update 6: Stemedica Paper Accepted for Presentation at ARVO
A safety study on the use of stem cells in the eye, in a clinical study underway at the Fyodorov Federal Institution of Eye Microsurgery in Moscow, to treat diabetic retinopathy and diabetic optical neuropathy with stem cells derived from bone marrow, has been accepted for presentation as a poster at the upcoming ARVO Annual Meeting in Fort Lauderdale at the beginning of May. An abstract is shown below.
In addition, my contact told me that Stemedica has registered in Clinical Trials, to conduct a Phase I/II multicenter trial under the auspices of UC San Diego, using bone marrow derived stem cells on patients with post ischemic strokes. The next step for the company will be to get a “green light” from the FDA to treat patients in the U.S., using the same type of cells on patients with retinal disorders. Those trials will include studies both with and without the use of a laser, as explained in my report on the company in the Primer on the Use of Stem Cells in Ophthalmology.
Phase I Study: Injection of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Patients with Diabetic Retinopathy and Diabetic Optical Neuropathy
Author Block: Natalia Gavrilova (1), Khristo Takhchidi (1), Irina Saburina (2), Nikolai Mironov (3), Marina Polyakova (1), Alexei Lukashev (4), Paul Tornambe (5).
(1) Ophthalmology, Fyodorov Federal Institution 'Eye Microsurgery', Moscow, Russian Federation; (2) Institute of General Pathology, Moscow, Russian Federation;
(3) Moscow Neurology Hospital, Moscow, Russian Federation;
(4) Stemedica Cell Technologies, San Diego, CA;
(5) Retina Consultants, San Diego, CA.
Purpose: Diabetic retinopathy (DP) and diabetic optical neuropathy (DON) are common complications of diabetes which are caused by abnormal development of retinal microvasculature. Initial case studies have been performed on human patients to assess the safety and efficacy of this type of cell therapy.
Methods: Six patients (4 female, 2 male, age 42-62) with early stages of diabetic retinopathy and diabetic optical neuropathy were injected intravenously with a single dose of 100M allogeneic bone marrow derived mesenchymal stem cells (BM MSC). The cells were manufactured under the guidelines of current good manufacturing practice (cGMP). All patients were examined prior to the injection and post injection on day 1, 14, 30, 2 month, 3 month, 6 month, one, two and three years. General examination included blood and urine panel, blood coagulation test and measurements of brain derived neurotrophic factor (BDNF) in blood plasma and tear fluid. Ophthalmic examination included visual acuity and ophtalmoscopic exam, perimetry test, optical coherent tomography(OCT), eletroretinography(ERG), electrooculography(EOG), Doppler ultrasound exam, optic disk color analysis.
Results: No adverse effects were observed or reported by all patients. During the whole period of follow up there were no changes in cardiovascular system, liver and kidney functionality. No infection growth, interstitial pneumonia or cancer was found in all patients. The positive changes in hemostatic dysfunctions and well as improvements in hemodynamic at systemic level were observed as early as two weeks after injection. Fovea sensitivity; functional activity of optic nerve, pigmented epithelium layer, outer and inner nuclear layers; BDNF content in blood plasma and tear fluids as well as optic disc inflammation were gradually improved during the first six months post injection and became stable during the whole period of follow up.
Conclusions: The results show safety of intravenous injection of BM MSC on patients with diabetic retinopathy and diabetic optical neuropathy. Positive changes of ophthalmic parameters should be further investigated in full scale clinical trails.