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Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa

Primary Purpose

Retinitis Pigmentosa

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
BMMNCs
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring retinitis pigmentosa, Bone marrow, stem cell, BMMNC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-65
  • Diagnosis of retinitis pigmentosa
  • willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation.
  • To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
  • willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

  • Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
  • Women who are pregnant or lactating
  • Complications of diabetic retinopathy.

Sites / Locations

  • Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BMMNCs

Arm Description

BMMNCs

Outcomes

Primary Outcome Measures

visual acuity
Electronic Visual Acuity (EVA) technology

Secondary Outcome Measures

Full Information

First Posted
July 31, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01914913
Brief Title
Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa
Official Title
An Open Labeled Clinical Study to Evaluate the Safety and Efficacy OF Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Retinitis Pigmentosa. It is Self Funded (Patients' Own Funding) Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is the layer of tissue at the back of the inner eye that converts light images to nerve signals and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is used for this condition .
Detailed Description
This study will involve about 8 visits over 1½ years .Each participant will be enrolled in study as per inclusion and exclusion criteria .Informed consent will be taken from subject before including in study. Subject will be underwent for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary outcome for this study will be a visual acuity score after one year of stem cell therapy . Follow-up visits will be required regularly to determine the effectiveness of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in RP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
retinitis pigmentosa, Bone marrow, stem cell, BMMNC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BMMNCs
Arm Type
Other
Arm Description
BMMNCs
Intervention Type
Biological
Intervention Name(s)
BMMNCs
Intervention Description
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Primary Outcome Measure Information:
Title
visual acuity
Description
Electronic Visual Acuity (EVA) technology
Time Frame
1 YEAR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-65 Diagnosis of retinitis pigmentosa willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation. To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study. willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol. Exclusion Criteria: Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis Women who are pregnant or lactating Complications of diabetic retinopathy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin P Jamadar, D.Ortho
Phone
918888788880
Email
sac2751982@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, MS ORTHO
Organizational Affiliation
Chaitanya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitanya Hospital
City
Pune,
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin P Jamadar, D ORTHO
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
Anant E Bagul, MS,Ortho

12. IPD Sharing Statement

Learn more about this trial

Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa

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