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WithdrawnNCT02024269Updated Sep 16, 2015

Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration

An interventional study of Adipose Derived Stem Cells in Dry Macular Degeneration, sponsored by Bioheart, Inc.. Withdrawn at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-09-16.

Sponsored by Bioheart, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
50 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Macular Degeneration

Keywords

  • macular degeneration
  • stem cells
  • adipose stem cells
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

Browse Macular Degeneration studies →

Lead sponsor

Bioheart, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Severe COPD or severe asthma that would contraindicate surgery
  • History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last two years.
  • Unwilling and/or not able to give written informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Adipose Stem Cells

    Biological: Adipose Derived Stem Cells

Interventions

  • BiologicalAdipose Derived Stem Cells
06

What researchers measure

Primary outcomes

  1. frequency and nature of adverse events

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

Secondary outcomes

  1. Intraocular pressure

    Time frame: 6 months

07

Study locations

1 site
  • Bioheart
    Sunrise, Florida, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02024269
Lead sponsor
Bioheart, Inc.
Responsible party
Sponsor
First posted
Dec 31, 2013
Start date
Dec 2013
Primary completion
Dec 2016 (estimated)
Completion
Jun 2017 (estimated)
Last update
Sep 16, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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