Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy

Allogeneic hematopoietic stem cell transplantation is a life-saving procedure for patients
with hematologic malignancies; yet wide application of this procedure is limited by the
availability of suitably Human Leukocyte Antigen (HLA) - matched donors. Only 30% of
patients who could benefit from this procedure have an HLA-matched sibling. The lengthy
search for a matched donor may critically delay transplantation. In addition, far fewer
patients of racial minorities find suitable HLA-matched donors. Umbilical cord blood (UCB)
has been increasingly used as an alternative source of stem cells; however, its use in
adults and adolescent patients is limited due to insufficient cell dose required for
satisfactory hematopoietic reconstitution.

Gamida Cell - Teva Joint Venture Ltd. is engaged in the development of StemEx®, an expanded
hematopoietic UCB stem cell graft, as a potential medicinal product for the treatment of
cancer and hematological malignancies. The expansion technology enables preferential
expansion of hematopoietic stem and early progenitor cells and is based on the findings that
copper chelators can regulate the balance between self-renewal and differentiation of stem
cells.

The multi-national, multi-center Phase II/III clinical study designated to evaluate the
safety and efficacy of StemEx® will enroll approximately 100 subjects with high-risk
hematologic malignancies who are candidates for allogeneic stem cell transplantation (SCT).
This study will evaluate the effect of StemEx® on overall survival as measured by overall
100-day mortality.

The study consists of 4 phases:

1. Screening phase includes subjects' clinical assessment and screening tests

2. Conditioning phase includes the myeloablative treatment prior transplantation procedure

3. Transplantation and post-transplant follow-up phase to day 180

4. Observational phase: survival status follow-up to day 730 (18 months)

Inclusion Criteria:

1. Clinical diagnosis of AML or ALL: CR2 or subsequent complete remission (CR) or CR1
with high-risk features or relapse with < 10% blasts in BM and no circulating blasts.

2. Clinical diagnosis of CML: in CP1 (Chronic Phase 1) and resistant or intolerant to
Gleevec or in CP2 or subsequent CP or in accelerated phase.

3. Clinical diagnosis of HD: induction failure or relapse and sensitive to last
chemotherapy course.

4. Clinical diagnosis of NHL induction failure or relapse and sensitive to last
chemotherapy course.

5. Clinical diagnosis of MDS with intermediate 2- or high-risk IPSS score.

Exclusion Criteria:

1. Less than twenty-one days have elapsed since the subject's last radiation or
chemotherapy prior to conditioning (except Hydroxyurea).

2. HIV positive.

3. Pregnancy or lactation.

4. Uncontrolled bacterial, fungal or viral infection.

5. Subjects with signs and symptoms of active central nervous system (CNS) disease.

6. Availability of appropriate related and willing stem cell donor, who is HLA-matched
at 5 or 6/6 antigens.

7. Prior allogeneic cell transplant.

8. Allergy to bovine or to any product, which may interfere with the treatment.

9. Enrolled in another clinical trial or received an investigational treatment during
the last 30 days, unless approved by Sponsor.