Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03772938
Other study ID # IKiKO-KB-0012/143/13
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date December 13, 2018
Est. completion date March 31, 2020

Study information

Verified date December 2018
Source Pomeranian Medical University Szczecin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of an autologous bone marrow-derived stem/progenitor cells administered intravitreously in the subjects with degenerative diseases of the retina.


Description:

Degenerative diseases of the retina are challenging for ophthalmologists. This is a common term that covers heterogenous group of diseases, f.e. retinitis pigmentosa, Stargardt disease, Best's disease or age related macular degeneration. Undetermined etiology, wide range of factors that may trigger the onset of the disease and modulate it's course impede the implementation of an effective treatment. Currently, a stem cells therapy seems to be promising option in patients with degenerative diseases of the retina. The purpose of this prospective, nonrandomized, open label, pilot study is to conduct the investigation of the safety and efficacy of intravitreal injection of autologous bone marrow-isolated stem/progenitor cells with different selected phenotypes into the subjects with degenerative diseases of the retina. Especially, this clinical trial is designated to test the therapeutic (pro-regenerative and neuro-protective) functions of different stem/progenitor cell populations able to secrete bioactive neurotrophic factors. All patients enrolled will have a documented history of degenerative disease of the retina prior to study enrollment. Next, autologous bone marrow-isolated stem/progenitor cells intravitreous injection will be performed. Finally, treatment safety, adverse events and exploratory parameters, including best corrected visual acuity, visual field and electroretinography parameters, to establish disease progression rate will be recorded throughout the duration of the post-treatment follow up period.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date March 31, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- diagnosed degenerative disease of the retina,

- age 18-65 years,

- best corrected visual acuity max. 0,2 (Snellen letter chart),

- good understanding of the protocol and willingness to consent,

- signed informed consent.

Exclusion Criteria:

- concomitant eye disease (glaucoma, etc.)

- concomitant of other systemic disease or diseases,

- inflammation (high protein or lymphocytosis in the CSF), active infections.

- diabetes,

- cardio-vascular disorders,

- cancer,

- autoimmune diseases,

- renal failure,

- impaired hepatic function,

- subject unwilling or unable to comply with the requirements of the protocol,

- patient has been treated previously with any cellular therapy,

Study Design


Intervention

Biological:
Stem/progenitor cells transplantation
Human autologous bone marrow-derived stem/progenitor cell transplantation administered as an intravitreal injection in patients with degenerative disease of retina.

Locations

Country Name City State
Poland I Department of Ophthalmology Szczecin

Sponsors (1)

Lead Sponsor Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Confirm the safety of autologous bone marrow stem/progenitor cell intravitreal injection in enrolled patients by repeated follow-up over one year with clinical evaluations. 12 months
Secondary Efficacy of autologous bone marrow stem/progenitor intravitreal injection in enrolled patients. Best corrected visual acuity, ETDRS chart [number of letters] 12 months
Secondary Intraocular pressure Pascal tonometer [mmHg] 12 months
Secondary Optic disk retinal nerve fiber layer optical coherence tomography [um] 12 months
Secondary Central macular thickness optical coherence tomography [um] 12 months
Secondary Ganglion cell complex thickness optical coherence tomography [um] 12 months
Secondary Choroidal thickness Enhanced depth imaging optical coherence tomography [um] 12 months
Secondary Choroidal volume Enhanced depth imaging optical coherence tomography [mm3] 12 months
Secondary Computed perimetry (30-2 and 10-2 module) mean deviation, pattern standard deviation [B] 12 months
Secondary Goldmann perimetry with color filters [degrees] 12 months
Secondary Contrast sensitivity Pelli-Robson chart [number of letters] 12 months
Secondary Function of the photoreceptors (rods and cones), inner retinal cells (bipolar and amacrine cells), and ganglion cells. Electroretinography (ERG) examination:
amplitude of a and b waves [V],
culmination time of a and b waves [s],
culmination time of q1-q3 waves [s].
12 months
Secondary Function of the photoreceptors Multifocal electroretinography (mfERG) examination:
retinal response density [V/degree 2],
culmination time of P1 wave in 6 rings [s].
12 months
Secondary Function of ganglion cells Pattern electroretinography (PERG) examination:
amplitude of P50 and N95 waves [V],
culmination time of P50 wave [s].
12 months
See also
  Status Clinical Trial Phase
Recruiting NCT01432847 - Cell Collection to Study Eye Diseases
Completed NCT04983914 - Retrospective NIS to Evaluate the Patient Benefit of TES
Recruiting NCT03845218 - Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures
Completed NCT00231010 - Molecular Genetics of Retinal Degenerations
Active, not recruiting NCT04611503 - PDE6A Gene Therapy for Retinitis Pigmentosa Phase 1/Phase 2
Completed NCT02909985 - Visual Activity Evoked by Infrared in Humans After Dark Adaptation N/A
Recruiting NCT01914913 - Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa Phase 1/Phase 2
Completed NCT01949623 - Biomarkers In Retinitis Pigmentosa (BIRP) N/A
Completed NCT01835002 - Transcorneal Electrical Stimulation - Multicenter Safety Study N/A
Completed NCT00407602 - Argus® II Retinal Stimulation System Feasibility Protocol N/A
Completed NCT00515814 - Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors N/A
Completed NCT00100230 - DHA and X-Linked Retinitis Pigmentosa Phase 2
Active, not recruiting NCT00378742 - Repository for Inherited Eye Diseases
Terminated NCT05085964 - An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa Phase 2
Recruiting NCT05805007 - Safety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa Early Phase 1
Recruiting NCT06291935 - Safety and Tolerability of Intravitreal Administration of VG901 in Patients With Retinitis Pigmentosa Due to Mutations in the CNGA1 Gene Phase 1
Recruiting NCT05909488 - Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II Phase 2/Phase 3
Recruiting NCT03078309 - The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients Early Phase 1
Completed NCT04238858 - Effects of Subtenon-injected Autologous Platelet-rich Plasma on Visual Functions in Eyes With Retinitis Pigmentosa N/A
Active, not recruiting NCT01680510 - The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil Phase 1/Phase 2