Clinical Trials

Multiple clinical trials are currently evaluating applications involving phytohemagglutinin across diverse conditions, including graft-versus-host disease, acute myeloid leukemia, acute lymphoblastic leukemia, other hematologic and non-hematologic malignancies, primary hyperaldosteronism, and hypertensive disorders of pregnancy. Sponsored by academic and clinical medical institutions such as Children's Hospital Los Angeles and Université de Sherbrooke in partnership with the Foundation of the Stars, these phase Not Applicable or unassigned studies currently range from not yet recruiting to actively recruiting patients.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05968170 Not yet recruiting
Graft Vs Host Disease|Graft-versus-host-disease|Acute Myeloid Leukemia|Acute Lymphoblastic Leukemia|Non-hematologic Malignancy|Hematologic Malignancy
Neena Kapoor M.D.|Children''s Hospital Los Angeles
 2023-12-01 Not Applicable
NCT05636995 Recruiting
Primary Hyperaldosteronism|Hypertensive Disorder of Pregnancy
Université de Sherbrooke|Foundation of the Stars
 2023-01-10 --

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Phytohemagglutinin (PHA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phytohemagglutinin binds cell surface glycoprotein receptors on lymphocytes to upregulate pro-apoptotic Bax expression and activate caspase-3, driving mitogenic blast transformation while suppressing humoral antibody responses. This selective T-cell activation and immunomodulatory capability provide a mechanistic framework for modulating immune rejection in graft-versus-host disease and targeting malignant cell proliferation in hematologic leukemias.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.