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

Use of autologous bone marrow (BM) derived stem cells for rehabilitation of patients with dry age related macular degeneration and retinitis pigmentosa

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000639

Enrollment

Registered

2010-07-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Bone Marrow Derived Mononuclear Cells: 8 Million Per Shot Control Intervention1: Control Arm Receiving The Standard Therapy:

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To study the safety of injected intravitreal stem cells.Timepoint: 1, 3, 6 months	—

Secondary

Measure	Time frame
To study efficacy of the injected intrvitreal stem cells.Timepoint: 1, 3, 6 months	—

Countries

India

Contacts

Public ContactDr. Sujata Mohanty

AIIMS

atul56kumar@yahoo.com011-26583194

Outcome results