Safety and Tolerability of hRPC in Retinitis Pigmentosa

This is a first-in-human open label phase I/II dose-escalation study in which participants
with retinitis pigmentosa will receive a single uni-ocular subretinal implantation of one of
three doses of hRPC.

Treated eyes will be carefully monitored for any ocular or systemic adverse events for 2
years.

Testing will comprise a series of detailed ophthalmic examinations and imaging together with
blood testing and systemic evaluations, as necessary.

Ophthalmic testing will also be evaluated for any preliminary efficacy signal.

Inclusion Criteria:

1. Have ability to give written informed consent as evidenced by signature on the subject
consent form.

2. Be adult male or female over 18 years of age.

3. Have clinical diagnosis of RP, based upon one or more of the following: clinical
features, medical imaging, electrophysiological measures and genetic testing, if
available. Genetic confirmation is not obligatory.

4. Have Best Corrected ETDRS visual acuity of 35 letters or less (approximately 20/200 or
worse) in the study eye for cohorts 1-5; have Best Corrected ETDRS visual acuity of 63
letters (approximately 20/63) to 36letters (approximately 20/200) in the study eye for
cohorts 6 and on.

5. Be medically able to undergo vitrectomy and subretinal injection.

6. Have good general health as defined by:

- Normal serum chemistry and hematology. Out of normal range laboratory findings
deemed not clinically significant are acceptable.

- No history of malignancy, except non-melanoma skin cancer; pre-malignant
conditions and cancer in situ.

- Negative serology for human immunodeficiency virus (HIV), hepatitis B (HBV),
hepatitis C (HCV).

- Medically fit enough to undertake surgery which may require general anesthesia.

- Free of any other systemic condition that in the opinion of the Investigator may
have an impact on the safety of the subject, conduct of study procedures, or
integrity of study data (e.g. severe cardiovascular or respiratory disease;
poorly controlled diabetes; significant psychiatric impairment).

7. Females of childbearing potential must have a confirmed negative pregnancy test at
Visits 1 and 2; and be willing to use reliable method of contraception (e.g. oral
contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with
spermicide and condom) for the duration of this study.

8. Males must be willing to use a reliable method of contraception (e.g. barrier and
spermicide) for the duration of this study; unless have been surgically sterilized
with confirmed azoospermia.

9. Be willing and able to attend all scheduled clinical assessments, ability to
communicate well with the Investigator and to comply with the expectations of the
study.

Exclusion Criteria:

1. Presence of ocular disease or ocular media opacity in the study eye, which in the
opinion of the Investigator, will preclude an accurate evaluation at any time during
the study.

2. History of any retinal and/or macular disease other than RP (e.g. retinal detachment)
that in the opinion of the Investigator may have an impact on the safety of the
subject, conduct of study procedures, or integrity of study data.

3. Active ocular infection or inflammation, or any history of intraocular inflammation,
that would expose subject to risk during or following surgery.

4. Prior vitrectomy in the study eye.

5. A history of amblyopia in the study eye.

6. High myopia (>6 diopters) in the study eye.

7. Cataract surgery in the study eye or ocular surgery in either eye (which in the
opinion of the investigator may have an impact on patient safety or the integrity of
data from the study eye) during the study or within 3 months prior to treatment.

8. Participation in any clinical study involving an investigational drug or device within
6 months prior to treatment.

9. Prior stem cell administration or injections to any part of the body (subjects who
have received autologous bone marrow stem cell transplant will be eligible).

10. Use of systemic immunosuppressive agents (e.g. corticosteroid) in the 6 months prior
to treatment (Note: inhaled, intranasal, and/or topical dermatologic steroids are
allowed).

11. (For females) Be breastfeeding or planning a pregnancy.

12. Known hypersensitivity to any of ingredients of the excipient.