Clinical trial NCT03609125: Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma
Official title: Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Neuro-Degenerative Disease
Keywords: cord blood
neuroprotection
growth factors
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2018-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A non-randomized, monocentric clinical study with a four month follow-up period , using a cord blood serum (CBS) eye drops in glaucoma patients. The purpose of the study analyzes whether the addition of CBS to hypotonic therapy is able to slow down the progression of anatomical and functional damage induced by glaucoma. The study evaluates the differences after two months of treatment as compared to baseline and after two-month from the end of the treatment.

Detailed description: The treatment of neuroprotection of degenerative ophthalmological diseases is currently proposed by administering products belonging to the category of food supplements (nutraceuticals containing amino acids and vitamins) or compounds of vegetable origin (Curcumin, flavonoids taken with food consumption of apples and oranges, LBP Polysaccharides from goji berries etc) or specific synthesis molecules (Memantine, Citicoline, Brimonidine, Omotaurina, Polyphenols).

The rationale for the use of eye drops prepared from the blood, and in particular Cord Blood Serum (CBS), as a source is mainly based on its content in growth factors (Growth factors, GF). with particular reference in neurotrophic GFs .

Enrollment of 20 patients with glaucoma and documented progressive retinal ganglion cells (RGC) dysfunction and degeneration was performed. The product to be administered was analyzed with respect to the levels of BDNF (Brain Derived Neurotrophic Factor), beta-NGF (Neural Growth Factor) , GDNF (Glial Derived Neuronal Factor), and EGF (Epidermal Growth Factor).

Functional, electro-physiological, and structural parameters were evaluated at baseline, after two months of treatment, and after two months from the end of the treatment.

Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):

1. Participant must be medically able to undergo the testing required in the schedule of visits
2. Participant's clinical diagnosis must be consistent with glaucoma, characterized by the following features:

   1. Clinical evidence of progressive retinal ganglion cell (RGC) dysfunction and degeneration using both visual field and at least one structural modality as established by: i. Glaucomatous visual field abnormality. ii. Mean deviation (MD) of -3 to -15 dB. iii. Minimum average retinal nerve fiber layer (RNFL) thickness of 60 μm and maximum average RNFL of 90 μm.
   2. Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in both eyes.
3. Participant's glaucoma must be clinically stable, with intraocular pressure (IOP) \< 21.

Exclusion Criteria:

1. Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
2. Participant is blind in one eye;
3. Participant has optic nerve atrophy
4. Participant is receiving systemic steroids or immunosuppressive drugs, or is on chemotherapy
5. Participant has a history of ocular herpes zoster.
6. Participant has uveitis or other ocular inflammatory disease.
7. Participant has a requirement of acyclovir
8. Participant has evidence of corneal opacification or lack of optical clarity.
9. Participant has diabetic macular edema and/or diabetic retinopathy.
10. Participant has a history of malignancy
11. Participant is pregnant or lactating.
12. History of use of drugs with known retinal toxicity

Primary outcomes:
measure: IOP (Intraocular pressure)
timeFrame: baseline, after two months of treatment, after two months from end of treatment
Secondary outcomes:
measure: BCVA (Best corrected visual acuity)
timeFrame: baseline, after two months of treatment, after two months from end of treatment
measure: Visual Field
timeFrame: baseline, after two months of treatment, after two months from end of treatment
measure: Fundus ophthalmoscopy
timeFrame: baseline, after two months of treatment, after two months from end of treatment
measure: Structural measure of retinal nerve fiber layer thickness
timeFrame: baseline, after two months of treatment, after two months from end of treatment
measure: ERG (Electroretinogram)
timeFrame: baseline, after two months of treatment, after two months from end of treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS AOUBO, Ophthalmology Unit
Study officials:
affiliation: AOU Policlinico S.Orsola-Malpighi and Alma Mater Studiorum University of Bologna
name: Luigi FONTANA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: