Pluripotin (SC1) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 447

Clinical Trials

Multiple clinical trials evaluate interventions across oncology, nephrology, and healthy volunteer cohorts, encompassing Phase 1 and combined Phase 1/Phase 2 protocols sponsored by entities including Amgen, Human Genome Sciences Inc., and the University of Colorado, Denver. Currently, a Phase 1/2 study in B-cell precursor acute lymphoblastic leukemia remains actively recruiting. Meanwhile, completed Phase 1 evaluations have addressed safety, pharmacokinetics, and bioavailability in subjects with chronic kidney disease as well as in healthy individuals.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04521231	Recruiting	B Cell Precursor Acute Lymphoblastic Leukemia	Amgen	2021-01-04	Phase 1\|Phase 2
NCT03126318	COMPLETED	Chronic Kidney Diseases	University of Colorado, Denver	2017-05-19	PHASE1
NCT01583530	COMPLETED	Healthy	Human Genome Sciences Inc.	2011-02	PHASE1

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

Check the Pluripotin (SC1) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pluripotin (SC1) directly inhibits dual targets extracellular signal-regulated kinase 1 (ERK1/MAPK3) and RasGAP, as well as downstream RSK family kinases, thereby suppressing the hyperactive Ras/MAPK signaling pathway to maintain stem cell self-renewal. By blocking these key pro-proliferative kinase cascades, the inhibitor helps restrain abnormal cellular proliferation and survival, providing direct therapeutic relevance to clinical conditions such as B-cell precursor acute lymphoblastic leukemia.

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>).