MedDataX Logo

Stem Cells Therapy in Degenerative Diseases of the Retina

NCT ID: NCT03772938

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-13

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Degeneration Retinitis Pigmentosa Age Related Macular Degeneration Stargardt Disease 1

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stem cells Retinitis Pigmentosa Age Related Macular Degeneration Stargardt Disease electroretinography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stem/progenitor cells transplantation

Intervention: A single intravitreal injection of autologous bone marrow-derived stem/progenitor cells will be performed.

Group Type ACTIVE_COMPARATOR

Stem/progenitor cells transplantation

Intervention Type BIOLOGICAL

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

Standard treatment of degenerative disease of retina

Symptomatic treatment of degenerative disease of retina without biologic cell-based treatment

Group Type SHAM_COMPARATOR

Stem/progenitor cells transplantation

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marta P. Wiącek

MD, PhD candidate, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bogusław Machaliński, MD, PhD

Role: STUDY_CHAIR

Pomeranian Medical University

Anna Machalińska, MD, PhD

Role: STUDY_DIRECTOR

Pomeranian Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

I Department of Ophthalmology

Szczecin, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IKiKO-KB-0012/143/13

Identifier Type: -

Identifier Source: org_study_id