A Study of Autologous Neo-Kidney Augment™ (NKA) in Type 2 Diabetics With Chronic Kidney Disease

NKA is made from expanded autologous selected renal cells obtained from each individual
subject's kidney biopsy. To manufacture NKA, biopsy tissue from each enrolled subject will be
sent to Twin City Bio LLC, in whose facilities renal cells will be expanded and SRC selected.
SRC will be formulated in a gelatin-based hydrogel at a concentration of 100 x 106 cells/mL,
packaged in a 10 mL syringe, and shipped to the clinical site.

Based on preclinical data, the dose of NKA will be 3 x 106 cells/g estimated kidney weight (g
KWest). Since the concentration of SRC per mL of NKA is 100 x 106 cells/mL, the dosing volume
will be 3.0 mL for each 100 g of kidney weight.

Subjects will be randomized (1:1) to the Active Treatment Group or the Deferred Treatment
Group following renal biopsy. Subjects in the Active Treatment Group will receive their first
NKA injection as soon as the NKA product is manufactured and shipped to the clinical site.
After 3 months (+12 weeks), a second injection will be given, as appropriate. In contrast,
subjects in the "Deferred Treatment Group" will undergo a period of observation after renal
biopsy. During this time, they will receive contemporaneous, standard-of-care therapy for CKD
while undergoing follow-up evaluations every 3 months similar to subjects in the Active
Treatment Group. After 12-18 months (maximum), subjects from the Deferred Treatment Group
will receive a series of up to two NKA injections given 3 months (+12 weeks) apart, as
appropriate. Consequently, the study design includes a randomized control group receiving
standard-of-care treatment for the first 12-18 months and a randomized, active treatment
group receiving up to two NKA injections and follow-up evaluations during the same period of
time. In addition, each subject's baseline rate of renal decline, based on adequate
historical, clinical data obtained 18 months prior to NKA injection, will serve as a
comparator for monitoring the rate of progression of renal insufficiency over time.

The rate of progression of renal insufficiency for the Active Treatment Group (assessed via
serial measurements of eGFR pre-randomization through 12 months after the last NKA injection)
will be compared against that of the Deferred Treatment Group (ie, contemporaneous control
group). In addition, each subject's baseline rate of eGFR decline (derived from adequate
historical, clinical data) will be compared against the individual subject's rate of eGFR
decline through 12 months following the final NKA treatment. The rate of progression of renal
insufficiency from subjects (if any) who received a single NKA injection may be compared
against that from subjects who received two NKA injections.

Subjects will complete the KDQOL survey, which is a kidney-specific measure of health-related
quality of life (ie, Kidney Disease and Quality of Life™ [KDQOL™-36] Version 1). Scores from
the Active Treatment Group will be compared against scores from the Deferred Treatment Group.
Subjects from the Deferred Treatment Group will comprise the contemporaneous control group
for the analysis of KDQOL scores. In addition, each subject's baseline scores will be
compared against the individual subject's KDQOL scores obtained through 12 months after the
last NKA injection. Additionally, KDQOL scores from subjects who received a single NKA
injection may be compared against scores from subjects who received two injections.

Inclusion Criteria:

1. The subject is male or female, 30 to 80 years of age on the date of informed consent.

2. The subject has an established diagnosis of T2DM.

3. The subject has an established diagnosis of diabetic nephropathy as the underlying
cause of renal disease.

4. The subject has an established diagnosis of CKD not requiring renal dialysis, defined
as having an eGFR between 20 and 50 mL/min/1.73m2 inclusive at the Screening Visit and
prior to NKA injection.

5. The subject has blood pressure less than 140/90 at the Screening Visit, prior to renal
biopsy, and prior to NKA injection(s). Note BP should not be significantly below
115/70.

6. The subject has stable blood pressure or has ongoing and stable treatment with an
angiotensin converting-enzyme inhibitor (ACEI) or an angiotensin receptor blocker
(ARB) initiated at least 8 weeks prior to renal biopsy. Treatment must be stable
during the 6-week period immediately prior to NKA injection. Stable treatment is
defined as dose adjustment no less than one-half of the current dosage and no more
than 2 times the current dosage. Dose interruptions up to 7 days due to medical
necessity are allowed. A subject who is intolerant or not currently on an ACEI or ARBs
may be included as long as he/she has stable blood pressure within the specified
limits.

7. A minimum of 2 measurements of eGFR or sCr should be obtained at least 3 months apart
prior to the Screening Visit or within the previous 18 months to define the rate of
progression of CKD. The subject should have adequate, historical clinical data to
provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor
may be consulted to ensure there is sufficient data.

8. The subject is willing and able to refrain from NSAID consumption (including aspirin)
as well as clopidogrel, prasugrel, or other platelet inhibitors during the period
beginning 7 days before through 7 days after both the renal biopsy and NKA
injection(s).

9. The subject is willing and able to refrain from consumption of fish oil and platelet
aggregation inhibitors, such as dipryridamole (ie, Persantine®), during the period
beginning 7 days before through 7 days after both the renal biopsy and NKA
injection(s).

10. The subject is willing and able to cooperate with all aspects of the protocol.

11. The subject is willing and able to provide signed informed consent.

Exclusion criteria:

1. The subject has a history of type 1 diabetes mellitus.

2. The subject has a history of renal transplantation.

3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.

4. The subject has uncontrolled diabetes (defined as metabolically unstable by the
Investigator).

5. The subject has hemoglobin levels less than 9 g/dL prior to each NKA injection.

6. The subject has abnormal coagulation status as measured by activated partial
thromboplastin time (APTT), prothrombin time-international normalized ratio (PT-INR),
and/or platelet count at the Screening Visit.

7. The subject has a bleeding disorder(s) or is taking anticoagulants, such as Coumadin®
(warfarin) or direct thrombin inhibitors that, in the judgment of the Investigator,
would interfere with the performance of study procedures.

8. The subject has small kidneys (average size less than 9 cm) or has only one kidney, as
assessed by ultrasound and/or MRI prior to renal biopsy, unless earlier radiology
reports (generated within 1 year of the Screening Visit) are made available to confirm
kidney size and number.

9. The subject has a known allergy or contraindication(s), or has experienced severe
systemicreaction(s) to kanamycin or structurally similar aminoglycoside antibiotic(s)

10. The subject has a history of anaphylactic or severe systemic reaction(s) or
contraindication(s) to human blood products or materials of animal origin (eg, bovine,
porcine).

11. The subject is not a good candidate to undergo percutaneous NKA injection, in the
judgment of the surgeon or physician who will perform the procedure. This includes
individuals who are morbidly obese (defined as BMI greater than 45 kg/m2), have
excessive fat surrounding the kidney, or who are otherwise at excessive risk for
serious complications.

12. The subject has a history of severe systemic reaction(s) or any contraindication to
local anesthetics or sedatives.

13. The subject has a clinically significant infection requiring parenteral antibiotics
within 6 weeks of NKA injection.

14. The subject has acute kidney injury or has experienced a rapid decline in renal
function during the last 3 months prior to NKA injection.

15. The subject has any of the following conditions prior to NKA injection: renal tumors,
polycystic kidney disease, anatomic abnormalities that would interfere with the NKA
injection procedure or evidence of a urinary tract infection.

16. The subject has incapacitating cardiac and/or pulmonary disorders.

17. The subject has a history of cancer within the past 3 years (excluding non-melanoma
skin cancer and carcinoma in situ of the cervix).

18. The subject has clinically significant hepatic disease (ALT or AST greater than
3-times the upper limit of normal) as assessed at the Screening Visit.

19. The subject is positive for active infection with Hepatitis B Virus (HBV), or
Hepatitis C Virus (HCV), and/or Human Immunodeficiency Virus (HIV) as assessed at the
Screening Visit.

20. The subject has a history of active tuberculosis (TB) requiring treatment within the
past 3 years.

21. The subject is immunocompromised or is receiving immunosuppressive agents, including
individuals treated for chronic glomerulonephritis within 3 months of NKA injection.
Note: inhaled corticosteroids and chronic low-dose corticosteroids (less than or equal
to 7.5 mg per day) are permitted as are brief pulsed corticosteroids for intermittent
symptoms (eg, asthma).

22. The subject has a life expectancy less than 2 years.

23. The female subject is pregnant, lactating (breast feeding), or planning a pregnancy
during the course of the study. Or, the female subject is of child-bearing potential
and is not using a highly effective method(s) of birth control, including sexual
abstinence. Or, the female subject is unwilling to continue using a highly-effective
method of birth control throughout the duration of the study. Note: A highly effective
method of birth control is defined as one that results in a low failure rate (ie, less
than one percent per year) when used consistently and correctly, such as implants,
injectables, combined oral contraceptives, some intrauterine devices IUDs, sexual
abstinence, or a vasectomized partner.

24. The subject has a history of active alcohol and/or drug abuse that, in the judgment of
the Investigator, would impair the subject's ability to comply with the protocol.

25. The subject's health status would, in the judgment of the Investigator, be jeopardized
by participating in the study.

26. The subject has used an investigational product within 3 months prior to NKA injection
without receiving written consent from the Medical Monitor.