Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ended
Participants planned
200
Countries
1
Sites
1
Not possible to specify
To evaluate the long-term safety of treatment with Cellcolabs produced MSCs.
Key facts
- Sponsor
- Cellcolabs AB
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- completed 24 Mar 2026
- Decision date (initial)
- 2025-01-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Cellcolabs AB
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacodynamic, Safety, Therapy
To evaluate the long-term safety of treatment with Cellcolabs produced MSCs.
Secondary objectives 2
- To evaluate long-term safety based on changes in Quality of Life.
- To exploratively evaluate long-term effects of treatment with Cellcolabs produced MSCs on laboratory parameters related to inflammation, immune system, and aging related processes.
Conditions and MedDRA coding
Not possible to specify
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10081224 | Stem cell therapy | 100000004865 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Participants priorly treated with Cellcolabs produced MSCs. Long-term safety follow-up of study participants treated with allogeneic Mesenchymal Stromal Cells (MSC) in humans
|
Not Applicable | None | Arm A: Prior treatment with Cellcolabs produced MSC's.: Participants priorly treated with Cellcolabs produced MSC's. Arm B: No prior MSC treatment received.: Participants with no prior MSC treatment received. |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517011-74-00 | Single center, decentralized, parallel group, open, non-randomized, long-term safety follow-up, and exploratory study of long-term effects on inflammatory, immunological, and aging related biomarkers in study participants treated with MSCs. | Cellcolabs AB |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- MSC Treatment Group A Having received treatment with Cellcolabs produced MSCs in any setting, within 12 months of inclusion. 2. Willing and able to comply with the study procedures. 3. Able to read and understand the participant information sheet and informed consent form.
- Non-treated Control Group B. Matching demographic and anthropometric criteria based on the existing cohort of MSC treated study participants. 2. Willing and able to comply with the study procedures, including blood sampling. 3. Able to read and understand the participant information sheet and informed consent form.
Exclusion criteria 1
- 1. It is not possible to verify with a reasonable degree of certainty what MSC treatment the participant received prior to joining the study (Group A only). 2. It is not possible to verify with a reasonable degree of certainty that individuals who are volunteering to join the non-treated control group, did not previously receive MSC treatment (Group B only). 3. Group B: Presents with diseases or conditions which are not present in the active treatment group (Group A) and which may impact significantly on the comparability of the groups. 4. Is not suitable for inclusion for any reason as judged by the investigator, i.e., long-term laboratory follow-up procedures not feasible due to old age.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Adverse Event and Serious Adverse Event rates, including clinically significant laboratory abnormalities.
Secondary endpoints 2
- Change from baseline and after MSC treatment in EQ-5D-5L dimensions
- Change from baseline in laboratory parameters.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
StromaForte MSC solution for infusion
PRD11428849 · Product
- Active substance
- Bone Marrow-Derived Mesenchymal Stem Cells
- Substance synonyms
- BM-MSC, BMMSC
- Pharmaceutical form
- CELL SUSPENSION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 5 million organisms million organisms
- Max total dose
- 5 million organisms million organisms
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELLCOLAB AB
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cellcolabs AB
- Sponsor organisation
- Cellcolabs AB
- Address
- Retzius Vag 8
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- Cellcolabs AB
- Contact name
- Agnes Le Blanc
Public contact point
- Organisation
- Cellcolabs AB
- Contact name
- Gustav Kamperman
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 200 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Study Protocol 2024-001-SWE V2 | 1 |
| Protocol (for publication) | Study Protocol 2024-001-SWE_V3_CLEAN | 3 |
| Protocol (for publication) | Study Protocol 2024-001-SWE_V3_TRACK CHANGES | 3 |
| Recruitment arrangements (for publication) | Forfarande-for-rekrytering-och-samtyckesprocess 2 | 1 |
| Recruitment arrangements (for publication) | Rekrytering till bada grupperna | 1 |
| Recruitment arrangements (for publication) | Rekrytering_annonstexter_V2_CLEAN | 2 |
| Recruitment arrangements (for publication) | Rekrytering_annonstexter_V2_TRACK CHANGES | 2 |
| Subject information and informed consent form (for publication) | 2024-001-SWE Samtyckesblankett_V02 | 1 |
| Subject information and informed consent form (for publication) | 2024-001-SWE_Information till forskningspersoner i kontrollgruppen - V02 | 1 |
| Subject information and informed consent form (for publication) | 2024-001-SWE_Information till forskningspersoner i kontrollgruppen_V3_CLEAN | 3 |
| Subject information and informed consent form (for publication) | 2024-001-SWE_Information till forskningspersoner i kontrollgruppen_V3_TRACK CHANGES | 3 |
| Subject information and informed consent form (for publication) | 2024-001-SWE_Information till forskningspersoner i MSC-gruppen - V02 | 1 |
| Subject information and informed consent form (for publication) | 2024-001-SWE_Information till forskningspersoner i MSC-gruppen_V3_CLEAN | 3 |
| Subject information and informed consent form (for publication) | 2024-001-SWE_Information till forskningspersoner i MSC-gruppen_V3_TRACK CHANGES | 3 |
| Synopsis of the protocol (for publication) | 2024-001-SWE_SYNOPSIS_V02 English | 1 |
| Synopsis of the protocol (for publication) | 2024-001-SWE_SYNOPSIS_V02 Svenska | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-31 | Sweden | Acceptable 2025-01-08
|
2025-01-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-27 | Sweden | Acceptable 2025-08-11
|
2025-08-13 |