Intervertebral Disc Regeneration by Autologous Stem Cell Transplantation

2024-514475-17-00 Phase I and Phase II (Integrated) - Other Ongoing, recruitment ended

Start 15 Nov 2022 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Ongoing, recruitment ended
Participants planned 34
Countries 1
Sites 1

degenerative disc disease

To monitor patient’s response and potential side effects of AD-MSC therapy in patients suffering from DDD compared to control group.

Key facts

Sponsor
Aarhus Universitet
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
15 Nov 2022 → ongoing
Decision date (initial)
2024-10-15
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Gigtforeningen · Aarhus University · Central Denmark Region

External identifiers

EU CT number
2024-514475-17-00
EudraCT number
2020-004754-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To monitor patient’s response and potential side effects of AD-MSC therapy in patients suffering from DDD compared to control group.

Secondary objectives 1

  1. MR morphology of disc: height, water content, fat and lipid, lactose, glucose, proteoglycans, collagen.

Conditions and MedDRA coding

degenerative disc disease

VersionLevelCodeTermSystem organ class
21.0 LLT 10070241 Degenerative disc disease 10028395

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 prospective randomized double blinded
Patients with DDD are randomized to either of two groups using block randomization in the program REDCap, an intervention group receiving AD-MSCs (n=17) and a control group receiving a sham operation (n=17)
 Randomised Controlled Double [{"id":126752,"code":3,"name":"Monitor"},{"id":126754,"code":2,"name":"Investigator"},{"id":126751,"code":5,"name":"Carer"},{"id":126753,"code":1,"name":"Subject"},{"id":126755,"code":4,"name":"Analyst"}] Arm 1: autologous Adipose-Derived Mesenchymal Stem Cells (AD-MSC): Will receive an intradiscal injection with 20 million AD-MSCs in 2 mL Ringer Acetat
Arm 2: control group: A needle skin puncture is performed on the back to
imitate the intradiscal injection.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Patients with lumbar back pain (max 2 levels)
  2. age 20 to 60 yrs,
  3. moderate disc degeneration (Pfirman grade 2-3)

Exclusion criteria 10

  1. Patients with lumbar back pain of other apparent reason such as: severe spinal stenosis, herniated disc, spondylolisthesis grade 2 or more.
  2. Age <20yrs, >60 yrs.
  3. Cognitive impairment.
  4. Treatment with cytostatic drugs.
  5. High risk of bleeding (bleeding disorder, taking anticoagulants etc.).
  6. Previous injections in disc.
  7. Pregnancy or breastfeeding.
  8. Conditions not compatible with MRI (non-compatible implants, claustrophobia, severe obesity).
  9. Tumors, infection or fracture in spine.
  10. Penicillin allergies.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

  1. Treatment success, pain reduction compared to control group Timeframe 2 yr, no post-intervention on treated level. No unexpected events by procedure.
  2. VAS-score
  3. pain diary
  4. EQ-5D
  5. ODI
  6. SF-36
  7. LBPRS

Secondary endpoints 1

  1. MR morphology of disc: height, water content, fat and lipid, lactose, glucose, proteoglycans, collagen.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

MSC, adipose tissue

PRD11497256 · Product

Active substance
Autologous Adipose-Derived Mesenchymal Stem Cells in Vitro Expanded
Substance synonyms
AdSC-JU
Other product name
Autologous Adipose-Derived Mesenchymal Stem Cells (AD-MSC) in suspension (20 million cells/ 2 mL Ringer Acetate)
Pharmaceutical form
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
INTRADISCAL USE
Authorisation status
Not Authorised
MA holder
REGION MIDTJYLLAND
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aarhus Universitet

9 Total trials 5 Recruiting 3 Ended
Academic / Non-commercial
Sponsor organisation
Aarhus Universitet
Address
Vennelyst Boulevard 4
City
Aarhus C
Postcode
8000
Country
Denmark

Scientific contact point

Organisation
Aarhus Universitet
Contact name
Michael Pedersen

Public contact point

Organisation
Aarhus Universitet
Contact name
Michael Pedersen

Third parties 2

OrganisationCity, countryDuties
Aarhus Universitet
ORG-100028380
 Aarhus N, Denmark On site monitoring, Code 9
Region Midtjylland
ORG-100009397
 Aarhus N, Denmark Code 14, Laboratory analysis

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruitment ended 34 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruitment ended
Aarhus Universitet
Department of Orthopedic surgery, Vennelyst Boulevard 4, 8000, Aarhus C

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2022-11-15 2022-11-15 2025-03-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2024-514475-17-00_redacted 8
Protocol (for publication) D4_Danish-EQ-5D-5L-Paper-Self-complete 1
Protocol (for publication) D4_LBPRS_function 1
Protocol (for publication) D4_ODI 2
Protocol (for publication) D4_Pain dairy 1
Protocol (for publication) D4_SF36 1
Protocol (for publication) D4_VAS_score 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_Informed Consent Form 1
Subject information and informed consent form (for publication) L1_SubjectInformationSheet_redacted 9
Subject information and informed consent form (for publication) L2_Dine rettigheder som forsgsperson i forsg med medicin 1
Synopsis of the protocol (for publication) D1_Protokol synopsis_DK_2024-514475-17-00_redacted 6

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-30 Denmark Acceptable
2024-10-11
 2024-10-15
2 SUBSTANTIAL MODIFICATION SM-1 2025-04-07 Denmark Acceptable
2025-05-26
 2025-05-27

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