Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa (TC/RP)

The Cellular Therapy Network (TerCel)

Status and phase: Completed; Phase 1

Conditions: Retinitis Pigmentosa

Treatments: Biological: Intravitreal injection of Autologous bone marrow Stem Cell; Other: Subconjunctival injection of saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02280135

TC/RP

2012-000618-12 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa by a prospective, single-center, randomized, parallel, double-blind, phase I placebo-controlled clinical trial.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Retinitis Pigmentosa bilateral diagnosis.
• Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below 30° central in both eyes.
• Signed informed consent
• Warranty sufficient adherence to protocol. It must fulfill all inclusion criteria.

Exclusion criteria

• Concurrence of any systemic or ocular disease that precludes or affects tracking study variables. Specifically retinal involvement with diabetes mellitus, glaucoma, macular degeneration or age.
• Eye surgery in the previous 6 months.
• Patients who are pregnant.
• Patients with active lactation.
• Physically fertile patients, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation excludes sexual intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS tHEY are using a reliable contraceptive method. This birth control method can be:
• Complete abstinence from sexual intercourse
• Surgical sterilization (tubal ligation)
• Surgical sterilization partner (vasectomy)
• Implanted or injectable hormonal contraceptives and oral.
• Patients with cardiac disease, renal, hepatic, systemic, immune that might influence the survival of patients during the test.
• Positive serology for hepatitis B, hepatitis C or HIV.
• Clinical criteria or anesthetics that contraindicate the sedation or the extraction of BM (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin in the puncture site, etc.)
• Participation in other clinical trials.
• Inability to sign informed consent or understanding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups, including a placebo group

Intravitreal injection of Autologous bone marrow Stem Cell

Experimental group

Description:

Patients included in the trial will receive a pars plana intravitreal injection of autologous mononuclear cells (MNC) of bone marrow (BM) in one eye (experimental group A or group). The eye in which autologous BM MNCs were injected will be determined randomly. The average dose will be 30 million of cells (5-60 million) diluted in 0.1 ml. of saline.

Treatment:

Biological: Intravitreal injection of Autologous bone marrow Stem Cell

Subconjunctival injection of saline

Placebo Comparator group

Description:

Patients included in the trial will receive a subconjunctival injection of 0.1 ml of saline (SF) (placebo) in the fellow eye (group B or control group). In this way the patient will receive an injection in the control eye but avoid the risks of intraocular injection.

Treatment:

Other: Subconjunctival injection of saline