Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation

Conditions

Incomplete HCT (Hematopoietic Cell Transplantation)

Brief summary

This study aims to evaluate the safety of intramuscular (IM) administration of PLX-R18 in subjects with incomplete hematopoietic recovery following HCT.

Joseph P. McGuirk, Leland Metheny, Luis Piñeiro, Mark R. Litzow, Scott D. Rowley et al. (13 authors)

Bone Marrow Transplantation2023-08-086 citations

10.1038/s41409-023-02068-3

PLX-R18 (Avoplacel), a Placental Expanded Mesenchymal-like Stromal Cell Therapy Shows Favorable Safety and Appears to Improve Incomplete Hematopoietic Recovery after Hematopoietic Cell Transplantation (HCT)

Hillard M. Lazarus, Joseph P. McGuirk, Tsila Zuckerman, Leland Metheny, Luis Piñeiro et al. (13 authors)

Blood2022-11-15

10.1182/blood-2022-169266

Safety and Demonstrated Efficacy of Placenta-Derived Cell Therapy PLX-R18 in Subjects with Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation: A Phase I International Multi-Center Study

Hillard M. Lazarus, Carolina Escobar, Leland Metheny, Joseph P. McGuirk, Tsila Zuckerman et al. (10 authors)

Blood2020-11-043 citations

10.1182/blood-2020-138662

Prospective, Multi-Center, Phase I Clinical Trial of PLX-R18 Placental Expanded Adherent Stromal Cells in Subjects with Incomplete Hematopoietic Recovery after Hematopoietic Cell Transplantation

Hillard M. Lazarus, Leland Metheny, Tsila Zuckerman, Carolina Escobar, Joseph P. McGuirk et al. (7 authors)

Blood2018-11-291 citations

10.1182/blood-2018-99-116239

Interventions

BIOLOGICALPLX-R18

Intramuscular (IM) administration of PLX-R18

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Age ≥18 years. 2. At least 3 months after HCT, either autologous or allogeneic (of any source, with any preparatory regimen, for any indication), prior to study treatment. 3. Sustained platelet count ≤50,000/µL, and/or sustained Hb ≤8 g/dL and/or sustained ANC ≤1000/mm3, attributed to graft failure as a major contributor, as evident by hypocellular bone marrow. Cytopenia should be confirmed by at least 2 consecutive blood counts, at least one of them within 28 days prior to treatment (higher transient levels following occasional blood product transfusions are allowed). 4. Stable donor cell chimerism in at least 3 consecutive tests prior to treatment (the most recent test should be within 28 days prior to treatment). 5. If the subject had allogeneic HCT for a malignant disease, the subject should have complete donor chimerism. \*complete donor chimerism should be determined by the investigator per site's standards. 6. General performance status evaluated by Eastern Cooperative Oncology Group 0-2 scale. 7. Signed written informed consent.

Exclusion criteria

INCLUSION AND

Design outcomes

Primary

Measure	Time frame
Emergent Adverse Events (AEs)	Recorded after time of consent throughout the study until the last visit (~1 year)
Safety laboratory values (including immunological testing)	Blood samples will be collected on each visit, through study completion (~1 year)
Vital signs	Will be assessed during each visit, through study completion (~1 year)
ECG	Will be assessed during the screening visit, before each IP treatment visit and on the 14th day of participation (visit 5).

Countries

Israel, United States

Outcome results

None listed