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Retinal DegenerationPhase 1/2NCT02144103

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

A Phase 1/2 study testing Subtenon administration of autologous ADRC, Liposuction and ADRC isolation in people with Retinal Degeneration and Primary Open-Angle Glaucoma, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 2 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Subtenon administration of autologous ADRC, Liposuction and ADRC isolation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesRussia
Study dates
May 2014to Jan 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Non-inclusion Criteria:
Show all 25Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

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

    Moscow, 119002

  • 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

Other trials in Russia

About this study

Official title: Effectiveness and Safety of Subtenon Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Glaucomatous Neurodegeneration

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.

Read the 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).

Being tested
Subtenon administration of autologous ADRC, Liposuction, ADRC isolation
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
Medical subject headings
Retinal Degeneration, Glaucoma, Open-Angle, Optic Nerve Diseases, Optic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subtenon administration of autologous ADRCOther

  • LiposuctionProcedure or surgery

  • ADRC isolationDevice

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

Study groups in NCT02144103
Study groupRoleWhat they receive
ADRC injectionExperimentalSubjects 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.
Receives: Other: Subtenon administration of autologous ADRC; Procedure: Liposuction; Device: ADRC isolation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SAEs and SARs monitoring

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

    Measured: 4 weeks after treatment

Secondary outcomes (7)

  1. Change in visual acuty

    Change from baseline in visual acuity assessed by visual acuty test

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

  2. Changes in structures of fundus of the eye-1

    Changes in structures of fundus of the eye assessed by funduscopy: changes of configuration and size of optic disc, neuroretinal rim thinning, degree of optic disc pallor, hemorrhages on the optic nerve and retina, vascular changes, presence of degenerative changes of retina, optic disc drusen, edema and retinal detachment.

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

  3. Changes in structures of fundus of the eye-2

    Changes in structures of fundus of the eye assessed by optical coherence tomography: changes of optic disc, neuroretinal rim and macula, retinal nerve fiber layer thickness.

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

  4. Change in visual field

    Change from baseline in visual field assessed by computer perimetry

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

  5. Change in retinal flicker responce

    Change from baseline in critical flicker fusion threshold

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

  6. Change in intraocular pressure

    Change from baseline in intraocular pressure assessed by pneumotonometry and tonography

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

  7. Quality of life monitoring

    Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36)., Visual Functioning-14 Quality of Life (VF-14 QOL) and Glaucoma Quality of Life-15 (GQL-15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJul 2018 (estimated)
  4. Study completionJan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144103
Sponsor's protocol ID
RU-CCH-02-01-14
Status last verified
Jul 2017
First submitted
9 May 2014
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Subtenon administration of autologous ADRC, Liposuction and ADRC isolation in people with Retinal Degeneration and Primary Open-Angle Glaucoma, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAEs and SARs monitoring (time frame: 4 weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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