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

NCT ID: NCT02144103

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-01-31

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.

Detailed Description

Fat tissue obtainment:

Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.

ADRC isolation:

Aspirated fat tissue placed into sterile vessel which inserted into Celution 800/CRS System (Cytori Therapeutics Inc) - closed system for automated and standardized extraction and concentration of ADRC. Celution 800/CRS System drains excess of fluid from fat tissue and estimate it's volume After that lipoaspirate washed extensively with equal volumes of Ringer's solution to remove blood. At the end of this process System indicates required volume of enzyme reagent (Celase®) which should be added immediately by operator. After enzyme treatment Celution 800/CRS System automatically transfers isolated ADRC into washing compartment where ADRC washed and concentrated in 5 mL suspension. Tissue processing time - approximately 60 minutes. ADRC suspension match all requirements listed in technical documentation for Celution 800/CRS System. Obtained ADRC divided into 2 portions. First portion (0.2-0.5 mL) used for counting, viability and sterility assessment. Second portion placed into sterile syringe for injection.

Subtenon injection of ADRC:

Antiseptic and anesthetic solutions instilled into conjunctival sac. After that blepharostat installed. The patient is asked to look in opposite to the injection side direction. Doctor inserts a needle into inferior temporal quadrant between rectus muscles,10-12 mm from the limbus. Needle should be moved slowly, as close as possible to the eyeball. After needle placement at the depth of 5-7 mm doctor injects concentrated solution of ADRC (up to 0,5 ml per single injection). Injection is made by insulin syringe with a needle size 0.45 mm * 12mm (26 G).

Conditions

Retinal Degeneration; Primary Open-Angle Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADRC injection

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.

Group Type: EXPERIMENTAL

Subtenon administration of autologous ADRC

Intervention Type: OTHER

Liposuction

Intervention Type: PROCEDURE

ADRC isolation

Intervention Type: DEVICE

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

Interventions

Subtenon administration of autologous ADRC

Intervention Type: OTHER

Liposuction

Intervention Type: PROCEDURE

ADRC isolation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
• Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
• Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
• Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
• Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration
• Medical history of heterotopic ossifications
• Patients prescribed for glycoprotein inhibitors treatment
• Acute vascular pathology
• Age-related macular degeneration

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alina K Drakon, MD

Role: STUDY_DIRECTOR

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

Ilya I Eremin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Julia P Sotnikova, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Moscow, , Russia

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, , Russia

Countries

Russia

Other Identifiers

RU-CCH-02-01-14

Identifier Type: -

Identifier Source: org_study_id