A clinical trial to evaluate the effect of bone marrow derived stem cell in diseases like dry age related macular degeneration and retinitis pigmentosa

Phase 1

• Registration Number: CTRI/2010/091/000639
• Lead Sponsor: Indian Council Of Medical Research, New Delhi, India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Dry Age related macular degeneration
1. Diagnosed Case of Dry ARMD
2. Age more than/ equal to 50 years
3. Willing to participate and able to come for follow up.
4. Duration of disease atleast one year.
5. Downhill or stable clinical course over 6 months.
6. Best corrected visual activity<= 3/60 and atleast FCCF with PR accurate.
7. Media clarity, pupillary dilation and patient cooperation sufficient for adequate fundus photography.
8. Informed Consent.
Retinitis Pigmentosa
1. Diagnosed Case of retinitis pigmentosa
2. Willing to participate and able to come for follow up.
3. Duration of disease atleast one year.
4. Downhill or stable clinical course over 6 months.
5. Best corrected visual activity<= 3/60 and atleast FCCF with PR accurate.
6. Media clarity, pupillary dilation and patient cooperation sufficient for adequate fundus photography.
7. Informed Consent.

Exclusion Criteria

Dry Age related macular degeneration
1. Evidence of exudative form (wet type) of ARMD.
2. Optic disc disease like glaucoma, optic atrophy from other causes.
3. Diabetic retinopathy.
4. Macular edema.
5. Non cooperative patient.
6. Patient not willing to consent.
Retinitis Pigmentosa
1. Age less than 18 years.
2. Optic disc disease like glaucoma, optic atrophy from other causes.
3. Diabetic retinopathy.
4. Bleeding disorder.
5. Non cooperative patient.
6. Patient not willing to consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the safety of injected intravitreal stem cells.Timepoint: 1, 3, 6 months

Secondary Outcome Measures

Name	Time	Method
To study efficacy of the injected intrvitreal stem cells.Timepoint: 1, 3, 6 months