Lucid Diligence Brief: Made Scientific and Cellergy Therapeutics manufacturing partnership to advance CLG-001

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Seven questions, 60-second thesis frame.

What changed, and when

Made Scientific and Cellergy Therapeutics announced on 24 Nov 2025 a manufacturing partnership to advance CLG-001, an intravenous donor-mitochondria product, toward first-in-human testing, including Israel MoH compassionate-use cases and a planned US Phase I under FDA oversight (PR Newswire release). Independent write-ups confirm the collaboration and clinical intent, though timelines are undisclosed (BioSpace pickup, Yahoo summary).

60-second thesis frame

This is a credible step for systemic mitochondrial transplantation, a nascent modality with early human precedent from Minovia’s ex-vivo mitochondrial augmentation programs and FDA designations, but still facing unresolved questions on product characterization, biodistribution, and long-term safety. The collaboration pairs a specialist CDMO with end-to-end GMP and QP release capabilities and Cellergy’s donor-derived, bioreactor-grown mitochondria designed for IV delivery, with initial access potentially via Israel’s compassionate-use mechanisms, then IND-enabled US entry (PR Newswire release, Chambers Life Sciences guide, Israel). Adjacent clinical signals show the field is moving, for example Minovia’s MAT entries on ClinicalTrials.gov and recent FDA orphan designation in MDS, but those are cell-based augmentations rather than direct mitochondrial infusions (ClinicalTrials.gov MNV-201, OncLive, FDA ODD). Regulatory context matters, reproductive mitochondrial replacement is restricted in the US, while somatic mitochondrial biologics would progress via IND and BLA under CBER oversight (FDA advisory on MRT).

The seven diligence questions

Clinical

• What are CLG-001’s first indications, target population, and IV dose-ranging logic, and how will the team quantify mitochondrial uptake and organ-level ATP restoration in humans, not just preclinical models?
• Which safety domains will be gatekeepers in FIH, for example immunogenicity to donor mitochondria, micro-embolization risk, and tumor metabolism concerns, and how will stopping rules be defined in the protocol?

Payer or Access

• If early access is via Israel MoH compassionate-use, what case selection criteria, pharmacovigilance, and HMO committee processes will govern access and funding, and how generalizable are outcomes to US and EU payers (Israel compassionate-use overview, Israel Journal of Health Policy Research study)?
• For the US, what is the anticipated benefit category and coding pathway for a hospital-administered biologic, and how will payer evidence needs differ from IND-phase signals?

Ops or Adoption

• Can Made Scientific transfer and scale Cellergy’s mitochondrial isolation and purification under cGMP with release specs that are clinically relevant, stable, and reproducible at lot scale (PR Newswire release)?

Competitive

• How differentiated is direct IV mitochondrial infusion versus cell-based mitochondrial augmentation programs already in, or approaching, human studies, and where will each modality win by indication or setting (ClinicalTrials.gov MNV-201, PubMed, compassionate-use SLSMDs)?

Team or Cap table

• Does the Cellergy leadership, advisory bench, and manufacturing governance have prior IND, BLA, or ATMP approvals in adjacent modalities, and how aligned are incentives with a CDMO partner through first dosing and beyond?

Red flags

• Regulatory ambiguity: donor-mitochondria products are likely regulated as biologics under CBER, yet there is little explicit FDA precedent for systemic IV mitochondrial transplantation in adults, raising classification and endpoint uncertainty (FDA advisory on MRT, reproductive context).
• CMC risk: release analytics for mitochondria, potency assays tied to clinical effect, and cold-chain logistics for organelles remain non-standardized, any failure in QC comparability could delay IND activation (PR Newswire release).
• Clinical external validity: encouraging signals exist in related augmentation approaches and case series, but they are limited in size and heterogeneity, and may not predict outcomes for direct IV mitochondrial infusion (PubMed SLSMDs case series, ClinicalTrials.gov MNV-201).

Next catalyst

Watch for tech-transfer completion and first GMP clinical lot with QP release at Made Scientific, plus initial CLG-001 trial registration or protocol posting for FIH and Israel MoH named-patient use, timing not disclosed in the announcement (PR Newswire release, Chambers Life Sciences guide, Israel).

FAQ

• What exactly changed by the Made Scientific and Cellergy manufacturing partnership to advance a first-in-human mitochondrial therapy on 24 Nov 2025, and why does it matter?
  The companies formalized a CDMO partnership to manufacture CLG-001, a donor-mitochondria IV product, supporting Israel compassionate-use and a planned US Phase I. This is one of the first industrial-scale attempts to move systemic mitochondrial transplantation into regulated human studies (PR Newswire release, BioSpace pickup).
• What is the regulatory path after the 24 Nov 2025 announcement by Made Scientific and Cellergy, and what are the next formal steps in the US and Israel?
  In the US, donor-mitochondria products would proceed via IND under CBER with eventual BLA if successful. In Israel, early access can proceed under MoH compassionate-use and clinical-trial frameworks governed by national guidelines and Helsinki Committees (FDA advisory, MRT policy context, Chambers Life Sciences guide, Israel).
• What nearby clinical evidence exists for mitochondrial therapies that informs expectations post-announcement of the partnership between Made Scientific and Cellergy?
  Minovia’s mitochondrial augmentation, a related but distinct ex-vivo approach, has FDA orphan designation for MNV-201 in MDS and ongoing early-phase studies, offering a precedent for regulatory engagement and feasibility. Case-series data in mtDNA deletion syndromes suggest potential multi-system benefit, though sample sizes are small (OncLive, FDA ODD, ClinicalTrials.gov MNV-201, PubMed SLSMDs compassionate-use).
• What safety issues matter most for Cellergy’s CLG-001 following the news on 24 Nov 2025 regarding the partnership between Cellergy and Made Scientific?
  Key concerns include immunogenicity to donor mitochondria, micro-vascular deposition, oncologic metabolism effects, and off-target tissue accumulation, all of which need prospective monitoring and potency-relevant release testing. The reproductive MRT ban in the US does not directly apply to somatic uses but signals FDA caution around mitochondrial interventions (FDA advisory, MRT).
• How might major US payers treat access after the 24 Nov 2025 announcement of the Made Scientific and Cellergy partnership, and are codes available?
  Until IND data exist, there is no defined coding or coverage for an IV mitochondrial biologic, so early US use will be confined to trials. Israel’s compassionate-use and HMO processes may enable early access and real-world signal generation to inform later payer discussions (Chambers Life Sciences guide, Israel, Israel Journal of Health Policy Research study).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 25 Nov 2025, — London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. Authors do not hold positions unless stated. © 2025 LucidQuest Ventures Ltd.

Entities / Keywords

Made Scientific; Cellergy Therapeutics; CLG-001; mitochondria transplantation; mitochondrial therapy; mitochondrial augmentation; Minovia Therapeutics; MNV-201; CBER; FDA; IND; BLA; compassionate use; Israel Ministry of Health; Helsinki Committee; Qualified Person; GMP Annex 1; clinical manufacturing; biodistribution; immunogenicity; mtDNA deletion syndromes; Pearson syndrome; Kearns-Sayre; neurodegeneration; metabolic disorders; aging; CDMO; ClinicalTrials.gov; orphan drug designation; payer access; HMO Israel; IV administration.

 

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