Back to results

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

Primary Purpose

Dry Macular Degeneration

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adipose Derived Stem Cells

About this trial

This is an interventional treatment trial for Dry Macular Degeneration focused on measuring macular degeneration, stem cells, adipose stem cells

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Bioheart

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adipose Stem Cells

Arm Description

Outcomes

Primary Outcome Measures

frequency and nature of adverse events

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.

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.

Secondary Outcome Measures

Intraocular pressure

Full Information

NCT ID

NCT02024269

First Posted

December 17, 2013

Last Updated

September 15, 2015

Sponsor

Bioheart, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02024269

Brief Title

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

Official Title

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Injected Intravitreal in Dry Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Withdrawn

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioheart, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Macular Degeneration

Keywords

macular degeneration, stem cells, adipose stem cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adipose Stem Cells

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Adipose Derived Stem Cells

Primary Outcome Measure Information:

Title

frequency and nature of adverse events

Time Frame

6 months

Title

Visual Field analysis (10-2)

Description

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

Title

Visual Acuity Measurements

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Intraocular pressure

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Facility Information:

Facility Name

Bioheart

City

Sunrise

State/Province

Florida

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs