NCT02024269

Brief Summary

This will be an open-label, non-randomized multi-center study of adipose stem cell (ASC) implantation. ASCs will be derived from the patient's adipose or fat. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via needle injection into the eye.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

December 17, 2013

Last Update Submit

September 15, 2015

Conditions

Dry Macular Degeneration

Keywords

macular degenerationstem cellsadipose stem cells

Outcome Measures

Primary Outcomes (3)

  • frequency and nature of adverse events

    6 months

  • Visual Field analysis (10-2)

    Visual field testing can be performed clinically by keeping the subject's gaze fixed while presenting objects at various places within their visual field.

    6 months

  • Visual Acuity Measurements

    Visual acuity is a measure of the spatial resolution of the visual processing system. VA is tested by requiring the person whose vision is being tested to identify so-called optotypes - stylized letters, Landolt rings or other patterns - on a chart from a set viewing distance.

    6 months

Secondary Outcomes (1)

  • Intraocular pressure

    6 months

Study Arms (1)

Adipose Stem Cells

EXPERIMENTAL
Biological: Adipose Derived Stem Cells

Interventions

Adipose Derived Stem CellsBIOLOGICAL
Adipose Stem Cells

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and Females between Age 50 and 90 years
  • Patients with dry AMD
  • Visual acuity in the study eye \<20200 (equal to or worse than 20/200)

You may not qualify if:

  • Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • Inability to undergo syringe liposuction procedure or have any medical problems that contraindicate the procedure.
  • Life expectancy \< 6 months due to concomitant illnesses.
  • Vitrectomized eyes
  • Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
  • Active infectious disease. . If patients have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis, an expert will be consulted as to patient eligibility based on the patient's infectious status
  • Any illness which might affect a patient's survival over the follow-up period
  • Any illness which, in the Investigator's judgement, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
  • Patients on chronic immunosuppressive transplant therapy
  • Patients with severe coagulation disorders
  • Systolic blood pressure (supine) ≤90 mmHg;
  • Resting heart rate \> 100 bpm;
  • Active clinical infection being treated by antibiotics within one week of enrollment.
  • Cerebrovascular accident within 6 months prior to study entry
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bioheart

Sunrise, Florida, United States

Location

MeSH Terms

Conditions

Geographic AtrophyMacular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 31, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

September 16, 2015

Record last verified: 2015-09

Locations

US(1)