Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Glaucomatous Neurodegeneration

NCT02144103 | Unknown Phase 1

• 1 other identifier: RU-CCH-02-01-14
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time into subtenon space of patient's eyeball. This is a single arm study with no control. All patients receive cell therapy.

Conditions

Retinal Degeneration; Primary Open-Angle Glaucoma

Keywords

Glaucomatous Neurodegeneration; Retinal Degeneration; Primary Open-Angle Glaucoma; Optic Neuropathy; Intraocular pressure; Retinal ganglion cell degeneration; Optic nerve atrophy; Subtenon injection; Glaucomatous damage; ADRC; Adipose-derived regenerative cells; Fat tissue; Stem cells

Outcome Measures

Primary Outcomes (1)

• SAEs and SARs monitoring

  Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs)

  4 weeks after treatment

Secondary Outcomes (7)

• Change in visual acuty

  Follow up to completion (up to 48 weeks after treatment)

• Changes in structures of fundus of the eye-1

  Follow up to completion (up to 48 weeks after treatment)

• Changes in structures of fundus of the eye-2

  Follow up to completion (up to 48 weeks after treatment)

• Change in visual field

  Follow up to completion (up to 48 weeks after treatment)

• Change in retinal flicker responce

  Follow up to completion (up to 48 weeks after treatment)

Study Arms (1)

ADRC injection

EXPERIMENTAL

Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected into subtenon space of patient's eye.

Other: Subtenon administration of autologous ADRC; Procedure: Liposuction; Device: ADRC isolation

Interventions

Subtenon administration of autologous ADRC OTHER

ADRC injection

Liposuction PROCEDURE

ADRC injection

ADRC isolation DEVICE

ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol

ADRC injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suffers from primary open-angle glaucoma (II and III stages; singe eye or both eyes) at least for 6 months
• Intraocular pressure is stable for at least for 3 months
• Visual acuity of each eye (measured by using visual acuity charts projector) not less than 0,1
• Patient is familiar with Participant information sheet
• Patient signed informed consent form
• Contraindications to the local anesthesia or medical history of allergic reactions to local anesthetics
• Any anomalies or conditions of at least one eye which can limit tonometry implementation
• Inflammatory disease of at least one eye or auxiliary apparatus (both infectious and non-infectious etiology: conjunctivitis, keratitis, uveitis, dacryocystitis etc.)
• Medical history of surgery on at least one eye during preceding 6 months.
• Medical history of heavy traumatic injury of eyes
• Patient has a cataract with high degree of lens opacification which can limit planned eye examination
• Patient prescribed for systemic corticosteroids or other medications treatment with proven effect leading on intraocular pressure increase
• Medical history or present dry eye syndrome accompanied by corneal and conjunctival xerosis
• Subcompensated or decompensated forms of chronic diseases of internal organs
• Clinically significant abnormalities in results of laboratory tests

You may not qualify if:

• Patient's refusal from the further participation in trial
• Patient's refusal from compliance with the requirements of contraception during the participation in research
• Chronic kidney disease IV- V stages (creatinine clearance \< 30 mL/min estimated by Cockroft-Gault formula)
• Confirmed syphilis, HIV, hepatitis B or C infections
• Dropout Criteria:
• Direct indications on immediate initiation of treatment with medications with proven effect leading to intraocular pressure increase
• Pregnancy
• Development of cataract with high degree of lens opacification which can limit planned eye examination

Sponsors & Collaborators

• Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation: lead

Study Sites (2)

Federal State Budgetary Institution "Outpatient Health Center №1" of the Business Administration for the President of the Russian Federation

Moscow, 119002, Russia

Location

Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies

Moscow, 121359, Russia

Location

MeSH Terms

Conditions

Retinal Degeneration; Glaucoma, Open-Angle; Optic Nerve Diseases; Optic Atrophy

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Glaucoma; Ocular Hypertension; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Alina K Drakon, MD

  Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

  STUDY DIRECTOR

• Ilya I Eremin, MD, PhD

  Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies

  PRINCIPAL INVESTIGATOR

• Julia P Sotnikova, MD

  Federal State Budgetary Institution "Outpatient Health Center №1" of the Business Administration for the President of the Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 21, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

RU (2)